GingivitisNCT07306117
A Person-centered, Theory-based, Intervention - Method Development Through the Integration of Digital Technology.
A study testing Person-centered, theory-based, intervention in people with Gingivitis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Studies have shown that Swedish adolescents have poor oral hygiene and with high prevalence of gingivitis. Therefore, more effective preventive programs in dental care are needed. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Person-centered, theory-based, intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents (16-17 years)
- Gingivitis and/or plaque on ≥50% of tooth surfaces at dental examination.
Who cannot join
- Adolescents judged as not capable to understand the study information in order to make a considered choice about participation (The Swedish Ethical Review Act; SFS 2003:460, § 18).
- Adolescents with obvious difficulties with the Swedish language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Person-centered, Theory-based, Intervention to Enhance Adolescents' Motivation for Adequate Oral Hygiene Behavior - Method Development Through the Integration of Digital Technology.
Studies have shown that Swedish adolescents have poor oral hygiene and with high prevalence of gingivitis. Therefore, more effective preventive programs in dental care are needed. The project aims to examine whether a health application and follow-up person-centered digital meetings can serve as support in person-centered and theory-based behavioral interventions to promote and maintain positive oral health habits.
Read the detailed description
Specific Aim - Purpose:
The overarching aim of the project is to develop more effective preventive programs targeting adolescents to promote oral/periodontal health.
Within the framework of the project, a clinical treatment study was recently conducted in which the investigators tested a person-centered, theory-based, behavioral intervention to strengthen adolescents' motivation for adequate oral hygiene behavior. The present study is a continuation of the project, focusing on method development of the intervention through the introduction of digital technology:
The specific aim of the present study is to:
- test a mobile health application as support/tool in person-centered, theory-based, interventions targeting young people in dental care, and
- explore whether person-centered digital maintenance meetings can be perceived as supportive for maintaining/promoting positive oral health/oral hygiene habits over time.
Background:
In Sweden, all children and adolescents are included in preventive programs within the free-of-charge dental care. Despite this, epidemiological studies show that adolescents have remarkably poor oral hygiene with a high prevalence of gingivitis. Gingivitis is a reversible condition, but if left untreated it can develop into chronic and destructive periodontitis. The prevalence of periodontitis is about 40% in the adult population, with associated consequences and significant costs for treatment/rehabilitation. The most important factor in preventing disease progression is establishing infection control through adequate daily oral hygiene. Dental professionals play a key role in educating and strengthening the individual's motivation for such health-promoting behavior.
Previous epidemiological studies have identified individual and environmental factors that interact with adolescents' health behavior and periodontal health status. When meeting young patients, it is important for dental professionals to consider such factors for a person-centered approach in interventions aimed at promoting health behaviors. Studies within dentistry indicate that behavioral interventions are more effective when based on theories of health behavior compared to conventional information/instruction in the treatment of adults with periodontitis. A systematic review concluded that key components of such theory-based interventions were that the individual:
(i) formulates personal goals for oral health and health behavior, (ii) plans for the implementation of the behavior in question, and (iii) monitors their behavior through self-monitoring (diary).
Furthermore, for positive behavior change to occur, it is crucial that the individual has knowledge and insight into their disease and understands the personal benefits of adopting a more health-oriented behavior. The use of a person-centered and collaborative communication method, such as motivational interviewing, by dental professionals also appears to be important in interventions aimed at improving oral health/oral hygiene behavior. However, there is a need for more studies in this area, including studies that do not only involve adult patients with periodontitis but also other patient/age groups. The importance of studies conducted in general dental practice has also been emphasized.
Based on knowledge generated in our own and others' studies, as described above, a randomized clinical field study was planned and conducted to test the effect of a person-centered, theory-based, intervention targeting adolescents to increase motivation for periodontal infection control, i.e., adequate oral hygiene behavior. The study included 312 adolescents (16-17 years), who were treated by dental hygienists (DH) in general dental care, Public Dental Service, Region Västra Götaland. The person-centered, theory-based intervention included components such as goal setting, planning, and self-monitoring of oral hygiene behavior, and DHs used motivational interviewing skills in communication (for further details see: ClinTrials.gov NCT02906098). Evaluation/results at six months showed that the person-centered, theory-based intervention (test) was more effective in establishing periodontal infection control compared to conventional information/instruction (control). In follow-up qualitative interviews with adolescents, feedback was provided on components of the test intervention that were perceived as working well and what could be improved. One finding from these interviews was that the written diary used by adolescents for self-monitoring of oral hygiene behavior was perceived as "old-fashioned" and difficult to keep track of, which meant that the diary was not always used as intended. Adolescents stated during interviews that they understood the benefit of the diary but that a mobile/smartphone application for self-monitoring could be an alternative that better suited their lives and needs. The use of smartphone applications has become an integral part of young people's lives, and there is growing interest in using such applications in interventions focused on behavioral change, but few studies have so far used such technology in interventions aimed at improving oral health habits. Furthermore, interviews with adolescents who participated in the previous treatment study also revealed a need for continued support after the initial intervention phase, which ended after six months, to maintain newly acquired and more positive oral health/oral hygiene habits over time. Interviews with DHs who treated adolescents within the framework of the previous treatment study confirmed adolescents' need for continued support but were hesitant to offer more physical visits and suggested that follow-up digital meetings could be an alternative, which the investigator also intend to introduce and test within the framework of the present pilot study. The introduction of digital meetings as a complement to in-person visits is becoming increasingly common in healthcare, but no studies has tested this in relation to person-centered interventions focusing on adolescents' oral health.
Significance:
Within the free-of-charge dental care system for children and adolescents, substantial resources are invested in the prevention of oral diseases. It is, of course, of utmost importance to continuously evaluate the measures implemented in dental care and to develop and improve methods that promote good oral health over time. Epidemiological data highlight the need to develop more effective methods to increase adolescents' motivation for improved oral hygiene and thereby prevent periodontal disease progression. Considering the prevalence of periodontitis in the population and the consequences/costs associated with the disease, effective preventive measures are of great significance. Studies indicate that behavioral interventions are more effective when based on theory of health behavior. These studies have mainly included adult patients with periodontitis treated in specialist clinics. There is a need for studies that include young individuals/patients and studies conducted in general dental care. The present project therefore contribute essential knowledge for the design of more effective preventive programs targeting young individuals in general dental care. The project may also provide insights of value beyond the dental care field regarding how to influence adolescents toward health-promoting behaviors.
Materials \& Methods:
The present study primarily adopts a qualitative methodological approach. The research team possesses solid expertise in qualitative methodology as well as other relevant knowledge and competencies necessary for the study's implementation.
Study Design and Participants:
Adolescents who, during a routine examination at the Public Dental Service, exhibit poor oral hygiene status (gingivitis and/or plaque on ≥50% of tooth surfaces) and who therefore are in need of individualized behavioral treatment will be informed about the study's purpose and asked if they are interested in participating. Approximately 25 patients/adolescents are planned to be included in the pilot study. These will be treated by five DHs (approximately five patients each) in accordance with the person-centered and theory-based intervention, but where the written diary for self-monitoring of oral hygiene behavior is replaced by a mobile health application. The application is intended to be used for self-monitoring during the active/initial phase of the behavioral intervention, which includes two physical and one digital visit over 12 weeks, followed by a follow-up/evaluation visit at six months. In addition, after completion of the initial intervention phase, the adolescents will be offered a person-centered digital maintenance meeting with their DH to promote/maintain positive oral health/oral hygiene habits. The maintenance phase covers the period from six to twelve months when the treatment in the pilot study ends.
Participating dental hygienists will undergo training prior to the study's implementation. During the implementation phase, a study coordinator will maintain regular contact with participating dental hygienists and provide support for any questions that may arise.
Data Collection \& Analysis:
Data collection will be carried out through focus group interviews, but questionnaire-based and clinical data will also be collected at baseline.
Semi-structured focus group interviews (4-6 participants per group) will be conducted with current study participants (adolescents and treating DH, respectively) after 12 months, focusing on:
(i) the design/content and usability/usefulness of the application, and (ii) experiences/usefulness of digital maintenance meetings.
Questionnaire-based data will be collected from adolescents at study start/baseline. The questions focus on personal background characteristics, self-rated oral and general health, and oral hygiene behavior. The questionnaire will be completed by the adolescents in the waiting room before treatment and placed by themselves in a sealed envelope. The questions have been tested in previous studies among adolescents. Clinical data (plaque and bleeding) will be recorded by the treating DH at baseline. Questionnaire-based and clinical data will only be presented descriptively.
Data obtained through focus group interviews will be analyzed using qualitative content analysis. NVivo software will be used for data management. The analysis will be conducted in close collaboration among team members representing different professional and research fields (Oral Health, Psychology, Education, and Nursing Science with a particular focus on person-centered care).
- Conditions
- Gingivitis
- Being tested
- Person-centered, theory-based, intervention
- Keywords
- Qualitative study, Gingivitis, Plaque, prevention, periodontal disease, behavioral change intervention, person-centered care, behavioral medicine, adolescents, oral health, oral hygiene, qualitative interviews
- Medical subject headings
- Gingivitis, Plaque, Amyloid, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centered, theory-based, interventionBehavioural
The person-centered intervention is based on theory of health behavior and includes behavior change techniques (personal goal setting for oral hygiene and oral health, planning, and monitoring of behavior). The dental hygienists use a collaborative communication method inspired by motivational interviewing. This intervention is the most recommended treatment for behavior change in cases of unhealthy lifestyle habits according to the National Guidelines for Dental Care (The National Board of Health and Welfare, 2022).
The initial intervention phase includes three visits:
Visit 1 (Baseline) - face-to-face (approx. 60 min) Visit 2 (2-3 weeks after baseline) - face-to-face (approx. 40 min) Visit 3 (10-12 weeks after baseline) - digital (approx. 30 min)
After 6 months, a follow-up is conducted (Visit 4 - face-to-face, approx. 40 min). Between 6 and 12 months (maintenance phase), one digital meeting is offered to support maintenance of new/positive oral hygiene habits.
| Study group | Role | What they receive |
|---|---|---|
| Person-centered, theory-based, intervention | Experimental | This treatment is the most recommended when behavioral change is needed to promote adequate oral hygiene - based on the Swedish National Guidelines for Dental Care (National Board of Health and Welfare, 2022). The aim is to, with a qualitative approach, explore views on the health application for self-monitoring and supportive person-centered digital maintenance meetings to promote new/positive oral hygiene habits. Receives: Behavioral: Person-centered, theory-based, intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interviews
This pilot study has mainly a qualitative approach where the adolescents and the dental hygienists who provide the treatment will be interviewed regarding experiences and views on the health application for self-monitoring and supportive person-centered digital meetings.
Measured: 12 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adolescents will be treated in accordance with the person-centered and theory-based intervention (based on social cognitive theory and including the behavioral change techniques goal setting, planing and self-monitoring) that was tested/evaluated in the previous treatment study, but where the written diary for self-monitoring of oral hygiene behavior is replaced by a mobile health application. The application is intended to be used for self-monitoring during the active/initial phase of the behavioral intervention, which includes two physical and one digital visit over 12 weeks, followed by a follow-up/evaluation visit at six months. In addition, after completion of the initial intervention phase, the adolescents will be offered a person-centered digital maintenance meeting as support to promote/maintain positive oral health/oral hygiene habits. The maintenance phase covers the period from six to twelve months when the treatment in the pilot study ends.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Sandra Lod Dimenäs, Göteborg University
- Investigators
- Sandra L. Dimenäs, Odont. Dr, Principal investigator, Departement of Periodontology, Institute of Odontology, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306117
- Sponsor's protocol ID
- Dnr: 2025-06217-01
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
PubMed 14769454National Board of Health and Welfare (2022). Nationella riktlinjer för tandvård - stöd för styrning och ledning 2022 (in Swedish). Retrieved from https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/nationella-riktlinjer/2022-9-8114.pdf in September 2025. Information in English about the guidelines: https://www.socialstyrelsen.se/en/clinical-practise-guidelines-and-regulations/regulations-and-guidelines/national-guidelines/
Ostberg AL, Ericsson JS, Wennstrom JL, Abrahamsson KH. Socio-economic and lifestyle factors in relation to priority of dental care in a Swedish adolescent population. Swed Dent J. 2010;34(2):87-94.
PubMed 20701217Werner H, Hakeberg M, Dahlstrom L, Eriksson M, Sjogren P, Strandell A, Svanberg T, Svensson L, Wide Boman U. Psychological Interventions for Poor Oral Health: A Systematic Review. J Dent Res. 2016 May;95(5):506-14. doi: 10.1177/0022034516628506. Epub 2016 Jan 29.
PubMed 26826109Wahlin A, Papias A, Jansson H, Norderyd O. Secular trends over 40 years of periodontal health and disease in individuals aged 20-80 years in Jonkoping, Sweden: Repeated cross-sectional studies. J Clin Periodontol. 2018 Sep;45(9):1016-1024. doi: 10.1111/jcpe.12978. Epub 2018 Jul 27.
PubMed 29971805Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.
PubMed 25639708Ericsson JS, Wennstrom JL, Lindgren B, Petzold M, Ostberg AL, Abrahamsson KH. Health investment behaviours and oral/gingival health condition, a cross-sectional study among Swedish 19-year olds. Acta Odontol Scand. 2016;74(4):265-71. doi: 10.3109/00016357.2015.1112424. Epub 2015 Nov 24.
PubMed 26599291Ericsson JS, Ostberg AL, Wennstrom JL, Abrahamsson KH. Oral health-related perceptions, attitudes, and behavior in relation to oral hygiene conditions in an adolescent population. Eur J Oral Sci. 2012 Aug;120(4):335-41. doi: 10.1111/j.1600-0722.2012.00970.x. Epub 2012 Jun 25.
PubMed 22813224Ericsson JS, Abrahamsson KH, Ostberg AL, Hellstrom MK, Jonsson K, Wennstrom JL. Periodontal health status in Swedish adolescents: an epidemiological, cross-sectional study. Swed Dent J. 2009;33(3):131-9.
PubMed 19994563Dimenäs SL. Behavioral Intervention for Improved Oral Hygiene in Adolescents - A Person-Centered and Theory-Based Approach. 2024. PhD-thesis, University of Gothenburg, Sweden.
Dimenas SL, Andersson JS, Jonsson B, Lundgren J, Petzold M, Ostberg AL, Abrahamsson KH. Adolescents' self-reported experiences following a person-centred, theory-based educational intervention versus conventional education for improved oral hygiene: Analysis of secondary outcomes of a randomized field study. J Clin Periodontol. 2024 Jan;51(1):63-73. doi: 10.1111/jcpe.13883. Epub 2023 Oct 11.
PubMed 37822115Dimenas SL, Jonsson B, Lundin M, Lundgren J, Abrahamsson KH. Changing from disease-centred to person-centred - Swedish dental hygienists' views on a theory-based behavioural intervention for improved oral hygiene among adolescents. Int J Dent Hyg. 2024 Nov;22(4):971-981. doi: 10.1111/idh.12811. Epub 2024 Apr 24.
PubMed 38659277Dimenas SL, Ostberg AL, Lundin M, Lundgren J, Abrahamsson KH. Adolescents' experiences of a theory-based behavioural intervention for improved oral hygiene: A qualitative interview study. Int J Dent Hyg. 2022 Nov;20(4):609-619. doi: 10.1111/idh.12606. Epub 2022 Aug 15.
PubMed 35925040Dimenas SL, Jonsson B, Andersson JS, Lundgren J, Petzold M, Abrahamsson I, Abrahamsson KH. A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study. J Clin Periodontol. 2022 Apr;49(4):378-387. doi: 10.1111/jcpe.13601. Epub 2022 Feb 23.
PubMed 35132653Dimenäs SL. Smartphone-applikationer vid beteendeförändring: En litteraturstudie med fokus på interventioner i syfte att påverka unga individers hälsobeteende. Examensarbete för magister i Oral Hälsa, 15 hp. Göteborgs universitet, 2017
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Person-centered, Theory-based, Intervention to Enhance Adolescents' Motivation for Adequate Oral Hygiene Behavior - Method Development Through the Integration of Digital Technology.
- ClinicalTrials.gov ID
- NCT07306117
- Acronym / sponsor ID
- Dnr: 2025-06217-01
- Conditions
- Gingivitis
- Keywords
- Qualitative study, Gingivitis, Plaque, prevention, periodontal disease, behavioral change intervention, person-centered care, behavioral medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have shown that Swedish adolescents have poor oral hygiene and with high prevalence of gingivitis. Therefore, more effective preventive programs in dental care are needed. The project aims to examine whether a health application and follow-up person-centered digital meetings can serve as support in person-centered and theory-based behavioral interventions to promote and maintain positive oral health habits.
Detailed description
Specific Aim - Purpose:
The overarching aim of the project is to develop more effective preventive programs targeting adolescents to promote oral/periodontal health.
Within the framework of the project, a clinical treatment study was recently conducted in which the investigators tested a person-centered, theory-based, behavioral intervention to strengthen adolescents' motivation for adequate oral hygiene behavior. The present study is a continuation of the project, focusing on method development of the intervention through the introduction of digital technology:
The specific aim of the present study is to:
- test a mobile health application as support/tool in person-centered, theory-based, interventions targeting young people in dental care, and
- explore whether person-centered digital maintenance meetings can be perceived as supportive for maintaining/promoting positive oral health/oral hygiene habits over time.
Background:
In Sweden, all children and adolescents are included in preventive programs within the free-of-charge dental care. Despite this, epidemiological studies show that adolescents have remarkably poor oral hygiene with a high prevalence of gingivitis. Gingivitis is a reversible condition, but if left untreated it can develop into chronic and destructive periodontitis. The prevalence of periodontitis is about 40% in the adult population, with associated consequences and significant costs for treatment/rehabilitation. The most important factor in preventing disease progression is establishing infection control through adequate daily oral hygiene. Dental professionals play a key role in educating and strengthening the individual's motivation for such health-promoting behavior.
Previous epidemiological studies have identified individual and environmental factors that interact with adolescents' health behavior and periodontal health status. When meeting young patients, it is important for dental professionals to consider such factors for a person-centered approach in interventions aimed at promoting health behaviors. Studies within dentistry indicate that behavioral interventions are more effective when based on theories of health behavior compared to conventional information/instruction in the treatment of adults with periodontitis. A systematic review concluded that key components of such theory-based interventions were that the individual:
(i) formulates personal goals for oral health and health behavior, (ii) plans for the implementation of the behavior in question, and (iii) monitors their behavior through self-monitoring (diary).
Furthermore, for positive behavior change to occur, it is crucial that the individual has knowledge and insight into their disease and understands the personal benefits of adopting a more health-oriented behavior. The use of a person-centered and collaborative communication method, such as motivational interviewing, by dental professionals also appears to be important in interventions aimed at improving oral health/oral hygiene behavior. However, there is a need for more studies in this area, including studies that do not only involve adult patients with periodontitis but also other patient/age groups. The importance of studies conducted in general dental practice has also been emphasized.
Based on knowledge generated in our own and others' studies, as described above, a randomized clinical field study was planned and conducted to test the effect of a person-centered, theory-based, intervention targeting adolescents to increase motivation for periodontal infection control, i.e., adequate oral hygiene behavior. The study included 312 adolescents (16-17 years), who were treated by dental hygienists (DH) in general dental care, Public Dental Service, Region Västra Götaland. The person-centered, theory-based intervention included components such as goal setting, planning, and self-monitoring of oral hygiene behavior, and DHs used motivational interviewing skills in communication (for further details see: ClinTrials.gov NCT02906098). Evaluation/results at six months showed that the person-centered, theory-based intervention (test) was more effective in establishing periodontal infection control compared to conventional information/instruction (control). In follow-up qualitative interviews with adolescents, feedback was provided on components of the test intervention that were perceived as working well and what could be improved. One finding from these interviews was that the written diary used by adolescents for self-monitoring of oral hygiene behavior was perceived as "old-fashioned" and difficult to keep track of, which meant that the diary was not always used as intended. Adolescents stated during interviews that they understood the benefit of the diary but that a mobile/smartphone application for self-monitoring could be an alternative that better suited their lives and needs. The use of smartphone applications has become an integral part of young people's lives, and there is growing interest in using such applications in interventions focused on behavioral change, but few studies have so far used such technology in interventions aimed at improving oral health habits. Furthermore, interviews with adolescents who participated in the previous treatment study also revealed a need for continued support after the initial intervention phase, which ended after six months, to maintain newly acquired and more positive oral health/oral hygiene habits over time. Interviews with DHs who treated adolescents within the framework of the previous treatment study confirmed adolescents' need for continued support but were hesitant to offer more physical visits and suggested that follow-up digital meetings could be an alternative, which the investigator also intend to introduce and test within the framework of the present pilot study. The introduction of digital meetings as a complement to in-person visits is becoming increasingly common in healthcare, but no studies has tested this in relation to person-centered interventions focusing on adolescents' oral health.
Significance:
Within the free-of-charge dental care system for children and adolescents, substantial resources are invested in the prevention of oral diseases. It is, of course, of utmost importance to continuously evaluate the measures implemented in dental care and to develop and improve methods that promote good oral health over time. Epidemiological data highlight the need to develop more effective methods to increase adolescents' motivation for improved oral hygiene and thereby prevent periodontal disease progression. Considering the prevalence of periodontitis in the population and the consequences/costs associated with the disease, effective preventive measures are of great significance. Studies indicate that behavioral interventions are more effective when based on theory of health behavior. These studies have mainly included adult patients with periodontitis treated in specialist clinics. There is a need for studies that include young individuals/patients and studies conducted in general dental care. The present project therefore contribute essential knowledge for the design of more effective preventive programs targeting young individuals in general dental care. The project may also provide insights of value beyond the dental care field regarding how to influence adolescents toward health-promoting behaviors.
Materials \& Methods:
The present study primarily adopts a qualitative methodological approach. The research team possesses solid expertise in qualitative methodology as well as other relevant knowledge and competencies necessary for the study's implementation.
Study Design and Participants:
Adolescents who, during a routine examination at the Public Dental Service, exhibit poor oral hygiene status (gingivitis and/or plaque on ≥50% of tooth surfaces) and who therefore are in need of individualized behavioral treatment will be informed about the study's purpose and asked if they are interested in participating. Approximately 25 patients/adolescents are planned to be included in the pilot study. These will be treated by five DHs (approximately five patients each) in accordance with the person-centered and theory-based intervention, but where the written diary for self-monitoring of oral hygiene behavior is replaced by a mobile health application. The application is intended to be used for self-monitoring during the active/initial phase of the behavioral intervention, which includes two physical and one digital visit over 12 weeks, followed by a follow-up/evaluation visit at six months. In addition, after completion of the initial intervention phase, the adolescents will be offered a person-centered digital maintenance meeting with their DH to promote/maintain positive oral health/oral hygiene habits. The maintenance phase covers the period from six to twelve months when the treatment in the pilot study ends.
Participating dental hygienists will undergo training prior to the study's implementation. During the implementation phase, a study coordinator will maintain regular contact with participating dental hygienists and provide support for any questions that may arise.
Data Collection \& Analysis:
Data collection will be carried out through focus group interviews, but questionnaire-based and clinical data will also be collected at baseline.
Semi-structured focus group interviews (4-6 participants per group) will be conducted with current study participants (adolescents and treating DH, respectively) after 12 months, focusing on:
(i) the design/content and usability/usefulness of the application, and (ii) experiences/usefulness of digital maintenance meetings.
Questionnaire-based data will be collected from adolescents at study start/baseline. The questions focus on personal background characteristics, self-rated oral and general health, and oral hygiene behavior. The questionnaire will be completed by the adolescents in the waiting room before treatment and placed by themselves in a sealed envelope. The questions have been tested in previous studies among adolescents. Clinical data (plaque and bleeding) will be recorded by the treating DH at baseline. Questionnaire-based and clinical data will only be presented descriptively.
Data obtained through focus group interviews will be analyzed using qualitative content analysis. NVivo software will be used for data management. The analysis will be conducted in close collaboration among team members representing different professional and research fields (Oral Health, Psychology, Education, and Nursing Science with a particular focus on person-centered care).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adolescents will be treated in accordance with the person-centered and theory-based intervention (based on social cognitive theory and including the behavioral change techniques goal setting, planing and self-monitoring) that was tested/evaluated in the previous treatment study, but where the written diary for self-monitoring of oral hygiene behavior is replaced by a mobile health application. The application is intended to be used for self-monitoring during the active/initial phase of the behavioral intervention, which includes two physical and one digital visit over 12 weeks, followed by a follow-up/evaluation visit at six months. In addition, after completion of the initial intervention phase, the adolescents will be offered a person-centered digital maintenance meeting as support to promote/maintain positive oral health/oral hygiene habits. The maintenance phase covers the period from six to twelve months when the treatment in the pilot study ends.
| Arm | Type | Receives |
|---|---|---|
| Person-centered, theory-based, intervention | Experimental | Behavioral: Person-centered, theory-based, interventionThis treatment is the most recommended when behavioral change is needed to promote adequate oral hygiene - based on the Swedish National Guidelines for Dental Care (National Board of Health and Welfare, 2022). The aim is to, with a qualitative approach, explore views on the health application for self-monitoring and supportive person-centered digital maintenance meetings to promote new/positive oral hygiene habits. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents (16-17 years)
- Gingivitis and/or plaque on ≥50% of tooth surfaces at dental examination.
Key exclusion criteria (2 listed)
- Adolescents judged as not capable to understand the study information in order to make a considered choice about participation (The Swedish Ethical Review Act; SFS 2003:460, § 18).
- Adolescents with obvious difficulties with the Swedish language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centered, theory-based, interventionThe person-centered intervention is based on theory of health behavior and includes behavior change techniques (personal goal setting for oral hygiene and oral health, planning, and monitoring of behavior). The dental hygienists use a collaborative communication method inspired by motivational interviewing. This intervention is the most recommended treatment for behavior change in cases of unhealthy lifestyle habits according to the National Guidelines for Dental Care (The National Board of Health and Welfare, 2022). The initial intervention phase includes three visits: Visit 1 (Baseline) - face-to-face (approx. 60 min) Visit 2 (2-3 weeks after baseline) - face-to-face (approx. 40 min) Visit 3 (10-12 weeks after baseline) - digital (approx. 30 min) After 6 months, a follow-up is conducted (Visit 4 - face-to-face, approx. 40 min). Between 6 and 12 months (maintenance phase), one digital meeting is offered to support maintenance of new/positive oral hygiene habits. | Behavioural | Person-centered, theory-based, intervention |
Primary outcome
Qualitative interviews
Time frame: 12 months after baseline.
This pilot study has mainly a qualitative approach where the adolescents and the dental hygienists who provide the treatment will be interviewed regarding experiences and views on the health application for self-monitoring and supportive person-centered digital meetings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 14769454Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
- BackgroundNational Board of Health and Welfare (2022). Nationella riktlinjer för tandvård - stöd för styrning och ledning 2022 (in Swedish). Retrieved from https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/nationella-riktlinjer/2022-9-8114.pdf in September 2025. Information in English about the guidelines: https://www.socialstyrelsen.se/en/clinical-practise-guidelines-and-regulations/regulations-and-guidelines/national-guidelines/
- Background: PubMed 20701217Ostberg AL, Ericsson JS, Wennstrom JL, Abrahamsson KH. Socio-economic and lifestyle factors in relation to priority of dental care in a Swedish adolescent population. Swed Dent J. 2010;34(2):87-94.
- Background: PubMed 26826109Werner H, Hakeberg M, Dahlstrom L, Eriksson M, Sjogren P, Strandell A, Svanberg T, Svensson L, Wide Boman U. Psychological Interventions for Poor Oral Health: A Systematic Review. J Dent Res. 2016 May;95(5):506-14. doi: 10.1177/0022034516628506. Epub 2016 Jan 29.
- Background: PubMed 29971805Wahlin A, Papias A, Jansson H, Norderyd O. Secular trends over 40 years of periodontal health and disease in individuals aged 20-80 years in Jonkoping, Sweden: Repeated cross-sectional studies. J Clin Periodontol. 2018 Sep;45(9):1016-1024. doi: 10.1111/jcpe.12978. Epub 2018 Jul 27.
- Background: PubMed 25639708Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.
- Background: PubMed 26599291Ericsson JS, Wennstrom JL, Lindgren B, Petzold M, Ostberg AL, Abrahamsson KH. Health investment behaviours and oral/gingival health condition, a cross-sectional study among Swedish 19-year olds. Acta Odontol Scand. 2016;74(4):265-71. doi: 10.3109/00016357.2015.1112424. Epub 2015 Nov 24.
- Background: PubMed 22813224Ericsson JS, Ostberg AL, Wennstrom JL, Abrahamsson KH. Oral health-related perceptions, attitudes, and behavior in relation to oral hygiene conditions in an adolescent population. Eur J Oral Sci. 2012 Aug;120(4):335-41. doi: 10.1111/j.1600-0722.2012.00970.x. Epub 2012 Jun 25.
- Background: PubMed 19994563Ericsson JS, Abrahamsson KH, Ostberg AL, Hellstrom MK, Jonsson K, Wennstrom JL. Periodontal health status in Swedish adolescents: an epidemiological, cross-sectional study. Swed Dent J. 2009;33(3):131-9.
- BackgroundDimenäs SL. Behavioral Intervention for Improved Oral Hygiene in Adolescents - A Person-Centered and Theory-Based Approach. 2024. PhD-thesis, University of Gothenburg, Sweden.
- Background: PubMed 37822115Dimenas SL, Andersson JS, Jonsson B, Lundgren J, Petzold M, Ostberg AL, Abrahamsson KH. Adolescents' self-reported experiences following a person-centred, theory-based educational intervention versus conventional education for improved oral hygiene: Analysis of secondary outcomes of a randomized field study. J Clin Periodontol. 2024 Jan;51(1):63-73. doi: 10.1111/jcpe.13883. Epub 2023 Oct 11.
- Background: PubMed 38659277Dimenas SL, Jonsson B, Lundin M, Lundgren J, Abrahamsson KH. Changing from disease-centred to person-centred - Swedish dental hygienists' views on a theory-based behavioural intervention for improved oral hygiene among adolescents. Int J Dent Hyg. 2024 Nov;22(4):971-981. doi: 10.1111/idh.12811. Epub 2024 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra L. Dimenäs, Odont. Dr principal investigator
Departement of Periodontology, Institute of Odontology, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centered, theory-based, intervention in people with Gingivitis, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews (time frame: 12 months after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07306117, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.