Periodontal Diseases InflammationNCT07914400
Timing of Oral Hygiene Improvement Relative to Subgingival Instrumentation
A study testing Nonsurgical periodontal treatment in people with Periodontal Diseases Inflammation and Periodontal Disease, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
This single-centre, randomized split-mouth trial assessed clinical periodontal changes and acute systemic inflammatory responses when supra- and subgingival instrumentation was performed concurrently with oral hygiene instruction or after 90 days of oral hygiene reinforcement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontal Diseases Inflammation, Periodontal Disease, Periodontal Attachment Loss
- What is being tested?
- Nonsurgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2023to 30 Sep 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18;
- generalized stage II-III, grade C periodontitis;
- FMPS and BOP indices ≥50% at baseline;
- ≥ 1 bleeding periodontal pocket ≥5 mm in each quadrant;
- ability to attend six-month follow-up;
- signed written informed consent.
Who cannot join
- Pregnancy or breastfeeding;
- chronic systemic disease;
- antibiotics in preceding six months;
- periodontal treatment in preceding 12 months;
- current smoking or cessation within five years;
- grade II or III furcation involvement.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Dental clinic - University Medical Centre Ljubljana and Faculty of Medicine University of Ljubljana
Ljubljana, Ljubljana, 1000
About this study
Official title: Effect of Oral Hygiene Improvement Before Versus at the Time of Subgingival Instrumentation on Clinical Periodontal Outcomes and High-Sensitivity C-Reactive Protein Levels: A Randomized Split-Mouth Clinical Trial
This single-centre, randomized split-mouth trial assessed clinical periodontal changes and acute systemic inflammatory responses when supra- and subgingival instrumentation was performed concurrently with oral hygiene instruction or after 90 days of oral hygiene reinforcement. Ten adults with periodontitis participated. One upper and one lower quadrant were randomly allocated to immediate instrumentation, while remaining quadrants received oral hygiene instruction and were instrumented at day 90. Clinical outcomes were evaluated at baseline, day 90 and day 180. High-sensitivity C-reactive protein was sampled before and 24 hours after each instrumentation session.
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of tooth-supporting tissues. Effective periodontal treatment requires both adequate supragingival plaque control and professional supra- and subgingival instrumentation. Although oral hygiene improvement is an essential component of periodontal therapy, the influence of its timing relative to subgingival instrumentation on clinical treatment outcomes and the acute systemic inflammatory response remains insufficiently understood.
The aim of this single-centre, randomized, controlled, split-mouth clinical trial was to investigate whether improving oral hygiene before periodontal instrumentation, compared with initiating oral hygiene improvement at the time of instrumentation, influences clinical periodontal outcomes and the acute systemic inflammatory response, assessed by changes in serum high-sensitivity C-reactive protein (hs-CRP) concentrations 24 hours after treatment.
Ten adults diagnosed with generalized periodontitis (Stage II or III, Grade C) were enrolled at the Department of Oral Medicine and Periodontology, University Medical Centre Ljubljana, Slovenia. All participants underwent a comprehensive periodontal examination, including measurements of probing pocket depth (PPD), clinical attachment level (CAL), gingival recession, bleeding on probing (BOP), and full-mouth plaque score (FMPS). Intraoral three-dimensional scans were obtained to assess changes in gingival soft-tissue morphology.
A computer-generated randomization procedure was used to allocate one maxillary and one mandibular quadrant in each participant to immediate periodontal instrumentation. These quadrants received supra- and subgingival instrumentation at baseline, together with individualized oral hygiene instruction and motivation. The remaining two quadrants initially received oral hygiene instruction without periodontal instrumentation. Participants were instructed in appropriate toothbrushing and interdental cleaning techniques and attended follow-up appointments for plaque assessment and reinforcement of oral hygiene practices.
At day 90, a comprehensive periodontal examination and intraoral scan were repeated. The previously untreated quadrants then underwent supra- and subgingival instrumentation, following 90 days of oral hygiene improvement. Additional follow-up visits were performed 1, 7, 14, and 30 days after each instrumentation session. The final periodontal examination and intraoral scan were conducted at day 180, corresponding to 90 days after instrumentation of the second group of quadrants.
Venous blood samples were collected immediately before and 24 hours after each instrumentation session to determine serum hs-CRP concentrations. These measurements were used to assess the acute systemic inflammatory response associated with periodontal instrumentation performed at different stages of oral hygiene improvement.
Clinical periodontal outcomes included changes in PPD, CAL, BOP, and plaque scores. Additional analyses evaluated treatment responses according to baseline periodontal pocket depth and assessed three-dimensional gingival soft-tissue changes using digital surface and volumetric comparisons.
The split-mouth design enabled comparisons between treatment approaches within the same participants, thereby reducing the influence of interindividual variability. The study was designed to provide preliminary evidence regarding the influence of oral hygiene improvement before subgingival instrumentation on periodontal healing and the acute systemic inflammatory response.
The study received approval from the National Medical Ethics Committee of the Republic of Slovenia (Approval No. 0120-417/2023/3). Written informed consent was obtained from all participants.
- Conditions
- Periodontal Diseases Inflammation, Periodontal Disease, Periodontal Attachment Loss, Periodontal Pocket, Oral Hygiene, Oral Hygiene Education
- Being tested
- Nonsurgical periodontal treatment
- Keywords
- Periodontitis, Oral Hygiene, Subgingival Instrumentation, Non-Surgical Periodontal Therapy, High-Sensitivity C-Reactive Protein (hs-CRP), Scaling and Root Planing, Systemic Inflammation, Periodontal Treatment Outcomes, Split-Mouth Randomized Clinical Trial, Gingival Soft Tissue Changes
- Medical subject headings
- Periodontal Diseases, Periodontal Attachment Loss, Periodontal Pocket, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical periodontal treatmentProcedure or surgery
All participants received individualized oral hygiene instructions and motivation at baseline. Supra- and subgingival instrumentation was performed in one randomly selected maxillary and one randomly selected mandibular quadrant at baseline. The remaining quadrants underwent the same instrumentation at day 90. Instrumentation was performed using ultrasonic instruments (PiezoLED, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA).
Full-Mouth Plaque Scores (FMPS) were assessed at follow-up visits on days 1, 7, 14, and 30 after each instrumentation session, and oral hygiene instructions were reinforced as needed to achieve an FMPS below 20% before instrumentation at day 90.
Venous blood samples were collected immediately before and 24 hours after each instrumentation session (at baseline and day 90) to measure serum high-sensitivity C-reactive protein (hs-CRP).
Three-dimensional (3D) intraoral scans were obtained at baseline, day 90, and day 180.
| Study group | Role | What they receive |
|---|---|---|
| Nonsurgical periodontal treatment | Experimental | Detailed oral hygiene instructions followed by two stage complete oral disinfection Receives: Procedure: Nonsurgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Measured: At baseline
Probing pocket depth (PPD)
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Measured: 90 days after first intervention
Probing pocket depth (PPD)
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Measured: 180 days after first intervention (90 days after second intervention)
Bleeding on probing (BOP)
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Measured: At baseline
Bleeding on probing (BOP)
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Measured: 90 days after first intervention
Bleeding on probing (BOP)
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Measured: 180 days after first intervention (90 days after second intervention)
Clinical attachment level (CAL)
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ).
Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
Unit: millimeters
Measured: At baseline
Clinical attachment level (CAL)
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ).
Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
Unit: millimeters
Measured: 90 days after first intervention
Clinical attachment level (CAL)
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ).
Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
Unit: millimeters
Measured: 180 days after first intervention (90 days after second intervention)
Plaque index (PI)
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Measured: At baseline
Plaque index (PI)
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Measured: 90 days after first intervention
Plaque index (PI)
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Measured: 180 days after first intervention (90 days after second intervention)
Secondary outcomes (6)
Change in serum hs-CRP from pre-instrumentation to 24 hours after
The absolute change in hs-CRP concentration (24-hour post-instrumentation value minus the pre-instrumentation value), expressed in mg/L.
Measured: Immediately before and 24 hours after baseline instrumentation
Change in serum hs-CRP from pre-instrumentation to 24 hours after
The absolute change in hs-CRP concentration (24-hour post-instrumentation value minus the pre-instrumentation value), expressed in mg/L.
Measured: Immediately before and 24 hours after instrumentation at day 90
Digital gingival surface area (mm²) deviations
Digital models were superimposed to evaluate gingival surface deviations over time. Changes in gingival surface area were quantified in square millimetres (mm²) and compared between quadrants
Measured: 90 days after first intervention
Digital gingival surface area (mm²) deviations
Digital models were superimposed to evaluate gingival surface deviations over time. Changes in gingival surface area were quantified in square millimetres (mm²) and compared between quadrants
Measured: 180 days after first intervention
Digital gingival volume (mm³) deviations
Digital models were superimposed to evaluate gingival surface deviations over time. Changes in gingival volume were quantified in cubic millimetres (mm³) and compared between quadrants
Measured: 90 days after first intervention
Digital gingival volume (mm³) deviations
Digital models were superimposed to evaluate gingival surface deviations over time. Changes in gingival volume were quantified in cubic millimetres (mm³) and compared between quadrants
Measured: 180 days after first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periodontal Diseases InflammationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Split-Mouth Randomized Prospective Clinical Trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Rok Schara, Doctor of dental medicine, Study director, University medical centre Ljubljana and Faculty of Medicine University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914400
- Sponsor's protocol ID
- OH and Periodontal Treatment
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.
Publications
Westfelt E, Rylander H, Dahlen G, Lindhe J. The effect of supragingival plaque control on the progression of advanced periodontal disease. J Clin Periodontol. 1998 Jul;25(7):536-41. doi: 10.1111/j.1600-051x.1998.tb02484.x.
PubMed 9696252Lindhe J, Nyman S. The effect of plaque control and surgical pocket elimination on the establishment and maintenance of periodontal health. A longitudinal study of periodontal therapy in cases of advanced disease. J Clin Periodontol. 1975 Apr;2(2):67-79. doi: 10.1111/j.1600-051x.1975.tb01727.x.
PubMed 1055729Cercek JF, Kiger RD, Garrett S, Egelberg J. Relative effects of plaque control and instrumentation on the clinical parameters of human periodontal disease. J Clin Periodontol. 1983 Jan;10(1):46-56. doi: 10.1111/j.1600-051x.1983.tb01266.x.
PubMed 6572634Graziani F, Gennai S, Marruganti C, Peric M, Ghiadoni L, Marhl U, Petrini M. Acute-phase response following one-stage full-mouth versus quadrant non-surgical periodontal treatment in subjects with comorbid type 2 diabetes: A randomized clinical trial. J Clin Periodontol. 2023 Apr;50(4):487-499. doi: 10.1111/jcpe.13760. Epub 2023 Jan 22.
PubMed 36517997Paterno Holtzman L, Valente NA, Vittorini Orgeas G, Copes L, Discepoli N, Clementini M. Change in clinical parameters after subgingival instrumentation for the treatment of periodontitis and timing of periodontal re-evaluation: A systematic review and meta-analysis. J Clin Periodontol. 2025 Jan;52(1):137-158. doi: 10.1111/jcpe.13985. Epub 2024 May 5.
PubMed 38706227Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4.
PubMed 37271498
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Hygiene Improvement Before Versus at the Time of Subgingival Instrumentation on Clinical Periodontal Outcomes and High-Sensitivity C-Reactive Protein Levels: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07914400
- Acronym / sponsor ID
- OH and Periodontal Treatment
- Conditions
- Periodontal Diseases Inflammation, Periodontal Disease, Periodontal Attachment Loss, Periodontal Pocket, Oral Hygiene, Oral Hygiene Education
- Keywords
- Periodontitis, Oral Hygiene, Subgingival Instrumentation, Non-Surgical Periodontal Therapy, High-Sensitivity C-Reactive Protein (hs-CRP), Scaling and Root Planing, Systemic Inflammation, Periodontal Treatment Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 Nov 2026 (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.
This single-centre, randomized split-mouth trial assessed clinical periodontal changes and acute systemic inflammatory responses when supra- and subgingival instrumentation was performed concurrently with oral hygiene instruction or after 90 days of oral hygiene reinforcement. Ten adults with periodontitis participated. One upper and one lower quadrant were randomly allocated to immediate instrumentation, while remaining quadrants received oral hygiene instruction and were instrumented at day 90. Clinical outcomes were evaluated at baseline, day 90 and day 180. High-sensitivity C-reactive protein was sampled before and 24 hours after each instrumentation session.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of tooth-supporting tissues. Effective periodontal treatment requires both adequate supragingival plaque control and professional supra- and subgingival instrumentation. Although oral hygiene improvement is an essential component of periodontal therapy, the influence of its timing relative to subgingival instrumentation on clinical treatment outcomes and the acute systemic inflammatory response remains insufficiently understood.
The aim of this single-centre, randomized, controlled, split-mouth clinical trial was to investigate whether improving oral hygiene before periodontal instrumentation, compared with initiating oral hygiene improvement at the time of instrumentation, influences clinical periodontal outcomes and the acute systemic inflammatory response, assessed by changes in serum high-sensitivity C-reactive protein (hs-CRP) concentrations 24 hours after treatment.
Ten adults diagnosed with generalized periodontitis (Stage II or III, Grade C) were enrolled at the Department of Oral Medicine and Periodontology, University Medical Centre Ljubljana, Slovenia. All participants underwent a comprehensive periodontal examination, including measurements of probing pocket depth (PPD), clinical attachment level (CAL), gingival recession, bleeding on probing (BOP), and full-mouth plaque score (FMPS). Intraoral three-dimensional scans were obtained to assess changes in gingival soft-tissue morphology.
A computer-generated randomization procedure was used to allocate one maxillary and one mandibular quadrant in each participant to immediate periodontal instrumentation. These quadrants received supra- and subgingival instrumentation at baseline, together with individualized oral hygiene instruction and motivation. The remaining two quadrants initially received oral hygiene instruction without periodontal instrumentation. Participants were instructed in appropriate toothbrushing and interdental cleaning techniques and attended follow-up appointments for plaque assessment and reinforcement of oral hygiene practices.
At day 90, a comprehensive periodontal examination and intraoral scan were repeated. The previously untreated quadrants then underwent supra- and subgingival instrumentation, following 90 days of oral hygiene improvement. Additional follow-up visits were performed 1, 7, 14, and 30 days after each instrumentation session. The final periodontal examination and intraoral scan were conducted at day 180, corresponding to 90 days after instrumentation of the second group of quadrants.
Venous blood samples were collected immediately before and 24 hours after each instrumentation session to determine serum hs-CRP concentrations. These measurements were used to assess the acute systemic inflammatory response associated with periodontal instrumentation performed at different stages of oral hygiene improvement.
Clinical periodontal outcomes included changes in PPD, CAL, BOP, and plaque scores. Additional analyses evaluated treatment responses according to baseline periodontal pocket depth and assessed three-dimensional gingival soft-tissue changes using digital surface and volumetric comparisons.
The split-mouth design enabled comparisons between treatment approaches within the same participants, thereby reducing the influence of interindividual variability. The study was designed to provide preliminary evidence regarding the influence of oral hygiene improvement before subgingival instrumentation on periodontal healing and the acute systemic inflammatory response.
The study received approval from the National Medical Ethics Committee of the Republic of Slovenia (Approval No. 0120-417/2023/3). Written informed consent was obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Split-Mouth Randomized Prospective Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Nonsurgical periodontal treatment | Experimental | Procedure: Nonsurgical periodontal treatmentDetailed oral hygiene instructions followed by two stage complete oral disinfection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18;
- generalized stage II-III, grade C periodontitis;
- FMPS and BOP indices ≥50% at baseline;
- ≥ 1 bleeding periodontal pocket ≥5 mm in each quadrant;
- ability to attend six-month follow-up;
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding;
- chronic systemic disease;
- antibiotics in preceding six months;
- periodontal treatment in preceding 12 months;
- current smoking or cessation within five years;
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 |
|---|---|---|
| Nonsurgical periodontal treatmentAll participants received individualized oral hygiene instructions and motivation at baseline. Supra- and subgingival instrumentation was performed in one randomly selected maxillary and one randomly selected mandibular quadrant at baseline. The remaining quadrants underwent the same instrumentation at day 90. Instrumentation was performed using ultrasonic instruments (PiezoLED, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA). Full-Mouth Plaque Scores (FMPS) were assessed at follow-up visits on days 1, 7, 14, and 30 after each instrumentation session, and oral hygiene instructions were reinforced as needed to achieve an FMPS below 20% before instrumentation at day 90. Venous blood samples were collected immediately before and 24 hours after each instrumentation session (at baseline and day 90) to measure serum high-sensitivity C-reactive protein (hs-CRP). Three-dimensional (3D) intraoral scans were obtained at baseline, day 90, and day 180. | Procedure or surgery | Nonsurgical periodontal treatment |
Primary outcome
Probing pocket depth (PPD)
Time frame: At baseline
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Probing pocket depth (PPD)
Time frame: 90 days after first intervention
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Probing pocket depth (PPD)
Time frame: 180 days after first intervention (90 days after second intervention)
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Bleeding on probing (BOP)
Time frame: At baseline
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Bleeding on probing (BOP)
Time frame: 90 days after first intervention
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Bleeding on probing (BOP)
Time frame: 180 days after first intervention (90 days after second intervention)
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Clinical attachment level (CAL)
Time frame: At baseline
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
Clinical attachment level (CAL)
Time frame: 90 days after first intervention
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
Clinical attachment level (CAL)
Time frame: 180 days after first intervention (90 days after second intervention)
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
Plaque index (PI)
Time frame: At baseline
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Plaque index (PI)
Time frame: 90 days after first intervention
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Plaque index (PI)
Time frame: 180 days after first intervention (90 days after second intervention)
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
6 secondary outcomes
Change in serum hs-CRP from pre-instrumentation to 24 hours after
Time frame: Immediately before and 24 hours after baseline instrumentation
Change in serum hs-CRP from pre-instrumentation to 24 hours after
Time frame: Immediately before and 24 hours after instrumentation at day 90
Digital gingival surface area (mm²) deviations
Time frame: 90 days after first intervention
Digital gingival surface area (mm²) deviations
Time frame: 180 days after first intervention
Digital gingival volume (mm³) deviations
Time frame: 90 days after first intervention
Digital gingival volume (mm³) deviations
Time frame: 180 days after first intervention
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 3 Nov 2026.
- Background: PubMed 9696252Westfelt E, Rylander H, Dahlen G, Lindhe J. The effect of supragingival plaque control on the progression of advanced periodontal disease. J Clin Periodontol. 1998 Jul;25(7):536-41. doi: 10.1111/j.1600-051x.1998.tb02484.x.
- Background: PubMed 1055729Lindhe J, Nyman S. The effect of plaque control and surgical pocket elimination on the establishment and maintenance of periodontal health. A longitudinal study of periodontal therapy in cases of advanced disease. J Clin Periodontol. 1975 Apr;2(2):67-79. doi: 10.1111/j.1600-051x.1975.tb01727.x.
- Background: PubMed 6572634Cercek JF, Kiger RD, Garrett S, Egelberg J. Relative effects of plaque control and instrumentation on the clinical parameters of human periodontal disease. J Clin Periodontol. 1983 Jan;10(1):46-56. doi: 10.1111/j.1600-051x.1983.tb01266.x.
- Background: PubMed 36517997Graziani F, Gennai S, Marruganti C, Peric M, Ghiadoni L, Marhl U, Petrini M. Acute-phase response following one-stage full-mouth versus quadrant non-surgical periodontal treatment in subjects with comorbid type 2 diabetes: A randomized clinical trial. J Clin Periodontol. 2023 Apr;50(4):487-499. doi: 10.1111/jcpe.13760. Epub 2023 Jan 22.
- Background: PubMed 38706227Paterno Holtzman L, Valente NA, Vittorini Orgeas G, Copes L, Discepoli N, Clementini M. Change in clinical parameters after subgingival instrumentation for the treatment of periodontitis and timing of periodontal re-evaluation: A systematic review and meta-analysis. J Clin Periodontol. 2025 Jan;52(1):137-158. doi: 10.1111/jcpe.13985. Epub 2024 May 5.
- Background: PubMed 37271498Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4.
- Individual participant dataSharing planned: No. All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.
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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.
Rok Schara, Doctor of dental medicine study director
University medical centre Ljubljana and Faculty of Medicine University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonsurgical periodontal treatment in people with Periodontal Diseases Inflammation and Periodontal Disease, run by University of Ljubljana at 1 site in Slovenia.
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 6 inclusion and 6 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 3 Nov 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 Slovenia. 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?
Probing pocket depth (PPD) (time frame: At baseline). The study lists 12 primary outcomes in all. 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 NCT07914400, which also lists 6 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 3 Nov 2026.