Bone ResorptionNCT06103799
Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients
A study testing IMB model-based continuity of care in people with Bone Resorption and Diabetes, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The investigators recruited 32 diabetic IOD patients with a total of 110 problematic implants who had completed the treatment for peri-implantitis between January 2021 and March 2023 as research subjects. The patients were randomly assigned to the control group or the experimental group using the random number table. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Resorption, Diabetes
- What is being tested?
- IMB model-based continuity of care
- 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
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria in this study were as follows:
- IOD patients who had type 2 diabetes with peri-implantitis in at least one implant,
- patients with clear consciousness and good communicative competence,
- patients who could take good care of themselves and were proficient in using mobile communication and internet devices
- patients who agreed to participate in our study.
Who cannot join
- Patients with any of the following were excluded from our study:
- type 1 diabetes and other particular types of diabetes,
- severe cognitive dysfunction or psychiatric disorders, and
- inability to use mobile electronic devices.
Trial locations and contacts
1 site in 1 country.
China1 site
The Stomatologic Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial
The investigators recruited 32 diabetic IOD patients with a total of 110 problematic implants who had completed the treatment for peri-implantitis between January 2021 and March 2023 as research subjects. The patients were randomly assigned to the control group or the experimental group using the random number table. The control group received routine postoperative medical advice, whereas the experimental group was given an IMB model-based continuity of care.
Read the detailed description
Continuity of care involves a series of actions designed to ensure that patients undergoing a transfer from different health care settings (e.g., from hospital to home) or within the same setting (e.g., different units in the hospital) receive different levels of collaborative and continuous care, including discharge planning, referrals, and continuous follow-up and guidance after the patient returns home . It encompasses the roles of both provider and receiver. Patients who actively participate will receive more substantial treatment. Additionally, a retrospective cohort study has shown that continuity of care is associated with lower risk of cardiovascular disease risk among individuals with type 2 diabetes. Another prospective cohort has shown that the application of continuity of care in the dental field enhances oral anticancer therapy adherence.
The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
This model may be particularly useful in diabetic IOD patients since they are more prone to peri-implantitis than patients with other types of implant restorations or non-diabetic patients. However, the efficacy of the combination of the IMB model and continuity of care in improving healing, bone resorption, disease management and control, and quality of life in the specific population group of diabetic IOD patients remains unclear. To this end, the current study was aimed at investigating whether this model of care can help achieve better clinical outcomes and improve patient satisfaction with the services provided, thereby obtaining data to serve as a reference and scientific basis for the improvement of intervention plans.
- Conditions
- Bone Resorption, Diabetes
- Being tested
- IMB model-based continuity of care
- Medical subject headings
- Bone Resorption, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB model-based continuity of careBehavioural
The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
| Study group | Role | What they receive |
|---|---|---|
| IMB model-based continuity of care | Experimental | Intervention through the IMB model-based continuity of care was focused on three aspects:
1. Information intervention: (a) instructing patients to follow the official account of the dental implant department and introducing the instructions to use the application, (b) regularly updating the educational content and disseminating detailed knowledge about the prevention and treatment of oral diseases, especially for peri-implantitis.
2. Motivation intervention: (a) providing an online platform for patients to interact with nurses and doctors, where they can obtain professional answers. (b) assessing the risk factors related to peri-implantitis and diabetes and developing appropriate interventions
3. Behavioral skills intervention: (a) providing feedback on the correct use of tools and implants and cleaning of the overdentures by observing the cleaning videos that the patients were required to upload. Receives: Behavioral: IMB model-based continuity of care |
| routine health education | No intervention | For the control group, standard care was provided in the form of routine health education regarding various topics, such as proper brushing techniques, use of an oral irrigator, and other auxiliary tools. The patients were followed-up via telephonic interviews to monitor their condition, including usage of the implant and lifestyle changes; the interviews were conducted at 2 weeks, 1 month, 3 months, and 6 months after treatment. Data were collected about oral health, blood glucose control, lifestyle habits, and comorbidities by using the compliance questionnaire. Appropriated health education was provided if there were any concerns such as gingival swelling, plaque accumulation, and elevated blood glucose levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant bone resorption
Each patient received at least 3 panoramic radiographs on the first day patients came to our hospital for treatment of peri-implantitis (T0), 6 months after treatment (T1), and 12 months after treatment (T2), respectively. The distances from the most coronal implant-bone junction site to the implant platform in both the mesial and distal sites of the implants were measured and recorded as measured mesial bone level (mMBL) and measured distal bone level (mDBL) respectively. The lengths of the implants were measured in order to calibrate the measurements by using the actual known length of the implant, for example, the actual MBL(aMBL) = mMBL × (actual implant length) / (measured implant length). We obtained the average value of aMBL and aDBL, regarded T0 as the baseline, and subtracted T0 from T1 or T2 to acquire the bone loss in 6 or 12 months after treatment.
Measured: 1-2years
Secondary outcomes (1)
Patient satisfaction
An in-house questionnaire was developed to assess the patients' satisfaction regarding nurses service attitude, timeliness of responses, effectiveness in controlling peri-implant inflammation, and feelings about their own condition. The scores ranged from 1 to 10, with higher scores indicating greater satisfaction.
Measured: 1-2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jan 2023
- Primary completion20 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhou, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103799
- Sponsor's protocol ID
- DHZhejiangU-2023(005)
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06103799
- Acronym / sponsor ID
- DHZhejiangU-2023(005)
- Conditions
- Bone Resorption, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Oct 2023 (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.
The investigators recruited 32 diabetic IOD patients with a total of 110 problematic implants who had completed the treatment for peri-implantitis between January 2021 and March 2023 as research subjects. The patients were randomly assigned to the control group or the experimental group using the random number table. The control group received routine postoperative medical advice, whereas the experimental group was given an IMB model-based continuity of care.
Detailed description
Continuity of care involves a series of actions designed to ensure that patients undergoing a transfer from different health care settings (e.g., from hospital to home) or within the same setting (e.g., different units in the hospital) receive different levels of collaborative and continuous care, including discharge planning, referrals, and continuous follow-up and guidance after the patient returns home . It encompasses the roles of both provider and receiver. Patients who actively participate will receive more substantial treatment. Additionally, a retrospective cohort study has shown that continuity of care is associated with lower risk of cardiovascular disease risk among individuals with type 2 diabetes. Another prospective cohort has shown that the application of continuity of care in the dental field enhances oral anticancer therapy adherence.
The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
This model may be particularly useful in diabetic IOD patients since they are more prone to peri-implantitis than patients with other types of implant restorations or non-diabetic patients. However, the efficacy of the combination of the IMB model and continuity of care in improving healing, bone resorption, disease management and control, and quality of life in the specific population group of diabetic IOD patients remains unclear. To this end, the current study was aimed at investigating whether this model of care can help achieve better clinical outcomes and improve patient satisfaction with the services provided, thereby obtaining data to serve as a reference and scientific basis for the improvement of intervention plans.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
| Arm | Type | Receives |
|---|---|---|
| IMB model-based continuity of care | Experimental | Behavioral: IMB model-based continuity of careIntervention through the IMB model-based continuity of care was focused on three aspects: 1. Information intervention: (a) instructing patients to follow the official account of the dental implant department and introducing the instructions to use the application, (b) regularly updating the educational content and disseminating detailed knowledge about the prevention and treatment of oral diseases, especially for peri-implantitis. 2. Motivation intervention: (a) providing an online platform for patients to interact with nurses and doctors, where they can obtain professional answers. (b) assessing the risk factors related to peri-implantitis and diabetes and developing appropriate interventions 3. Behavioral skills intervention: (a) providing feedback on the correct use of tools and implants and cleaning of the overdentures by observing the cleaning videos that the patients were required to upload. |
| routine health education | No intervention | –For the control group, standard care was provided in the form of routine health education regarding various topics, such as proper brushing techniques, use of an oral irrigator, and other auxiliary tools. The patients were followed-up via telephonic interviews to monitor their condition, including usage of the implant and lifestyle changes; the interviews were conducted at 2 weeks, 1 month, 3 months, and 6 months after treatment. Data were collected about oral health, blood glucose control, lifestyle habits, and comorbidities by using the compliance questionnaire. Appropriated health education was provided if there were any concerns such as gingival swelling, plaque accumulation, and elevated blood glucose levels. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- IOD patients who had type 2 diabetes with peri-implantitis in at least one implant,
- patients with clear consciousness and good communicative competence,
- patients who could take good care of themselves and were proficient in using mobile communication and internet devices
- patients who agreed to participate in our study.
Key exclusion criteria (4 listed)
- type 1 diabetes and other particular types of diabetes,
- severe cognitive dysfunction or psychiatric disorders, and
- inability to use mobile electronic devices.
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 |
|---|---|---|
| IMB model-based continuity of careThe information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered. | Behavioural | IMB model-based continuity of care |
Primary outcome
Peri-implant bone resorption
Time frame: 1-2years
Each patient received at least 3 panoramic radiographs on the first day patients came to our hospital for treatment of peri-implantitis (T0), 6 months after treatment (T1), and 12 months after treatment (T2), respectively. The distances from the most coronal implant-bone junction site to the implant platform in both the mesial and distal sites of the implants were measured and recorded as measured mesial bone level (mMBL) and measured distal bone level (mDBL) respectively. The lengths of the implants were measured in order to calibrate the measurements by using the actual known length of the implant, for example, the actual MBL(aMBL) = mMBL × (actual implant length) / (measured implant length). We obtained the average value of aMBL and aDBL, regarded T0 as the baseline, and subtracted T0 from T1 or T2 to acquire the bone loss in 6 or 12 months after treatment.
1 secondary outcome
Patient satisfaction
Time frame: 1-2years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMB model-based continuity of care in people with Bone Resorption and Diabetes, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 27 Oct 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peri-implant bone resorption (time frame: 1-2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.