PeriodontitisNCT07450573
Impact of Periodontal Therapy on Function and Quality of Life in Stage III Periodontitis
A study testing non-surgical periodontal treatment and surgical periodontal treatment in people with Periodontitis, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Stage III, Grade B periodontitis is a severe form of gum disease that damages the tissues and bone supporting the teeth. It can cause loose teeth, difficulty chewing, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 31 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- non-surgical periodontal treatment and surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 5 Jul 2021
- 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 31 to 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥ 20 natural teeth
- at least four functional chewing units (one molar pair = two units; one premolar pair = one unit).
- positive bleeding on probing in ≥ four chewing units
- probing depth ≥ 5 mm in ≥ four molar or premolar teeth
- age between 20 and 45 years.
Who cannot join
- Individuals with systemic diseases
- pregnancy
- smoking habits
- recent antibiotic or anti-inflammatory use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol University
Ankara, Ankara, 06010
About this study
Stage III, Grade B periodontitis is a severe form of gum disease that damages the tissues and bone supporting the teeth. It can cause loose teeth, difficulty chewing, and reduced quality of life. Although periodontal (gum) treatment is known to improve gum health, less is known about how it affects chewing ability and how patients feel about their oral health after treatment.
This study looked at how comprehensive periodontal treatment affects gum health, chewing function, and oral health-related quality of life. Twenty patients with Stage III, Grade B periodontitis and twenty individuals with healthy gums participated. Patients with periodontitis received non-surgical treatment (deep cleaning and root surface debridement) followed, when needed, by surgical periodontal therapy.
Read more
Researchers measured gum health (including probing depth and bleeding), tooth mobility, chewing performance, and patient-reported quality of life. Chewing performance was tested using a standardized chewing test with silicone material. Quality of life was assessed using a validated questionnaire (OHIP-14), which measures how oral health affects daily life, comfort, and well-being.
Assessments were performed before treatment, after non-surgical therapy, and after surgical treatment.
At the start of the study, patients with periodontitis had worse gum health, poorer chewing ability, and lower oral health-related quality of life compared to healthy individuals. After treatment, gum inflammation and tooth mobility significantly improved. Chewing ability also improved after therapy, especially after surgical treatment. Patients reported better quality of life, with fewer symptoms and less discomfort.
The study also found that better chewing performance was strongly associated with better quality of life. This suggests that improving function is closely linked to how patients feel about their oral health.
Overall, comprehensive periodontal therapy not only improves clinical gum health but also enhances chewing efficiency and patient well-being. These findings highlight the functional and quality-of-life benefits of periodontal rehabilitation in patients with advanced gum disease.
Read the detailed description
Stage III, Grade B periodontitis is characterized by advanced periodontal attachment loss, deep periodontal pockets, tooth mobility, and radiographic bone loss. In addition to structural damage, this condition may impair masticatory efficiency and negatively affect oral health-related quality of life (OHRQoL). While conventional periodontal therapy effectively reduces inflammation and stabilizes periodontal tissues, its functional and patient-reported outcomes in advanced disease stages require further clarification.
This prospective controlled clinical study was designed to evaluate the impact of comprehensive periodontal therapy on clinical periodontal parameters, objective masticatory performance, and OHRQoL in patients with Stage III, Grade B periodontitis.
Study Population: The study included 20 systemically healthy patients diagnosed with Stage III, Grade B periodontitis and 20 periodontally healthy individuals serving as controls. Participants were recruited from a university dental clinic. Inclusion criteria for the periodontitis group were consistent with current periodontal classification guidelines. Exclusion criteria included systemic diseases affecting periodontal status, recent periodontal treatment, smoking, pregnancy, and use of medications known to influence periodontal tissues.
Study Design and Interventions: At baseline, all participants underwent comprehensive periodontal examination, including; Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL), Tooth mobility measured using Periotest. Masticatory performance was assessed using a standardized silicone cube chewing test. Participants chewed the test material for a defined number of cycles. The comminuted material was sieved through multiple apertures to calculate objective performance indices. OHRQoL was evaluated using the validated Oral Health Impact Profile (OHIP-14) questionnaire.
Patients in the periodontitis group received: Non-surgical periodontal therapy (scaling and root planing) and surgical periodontal therapy when indicated, following re-evaluation. Clinical and functional assessments were repeated after completion of non-surgical therapy and again following surgical treatment. The healthy control group was evaluated once for baseline comparison.
Outcome Measures:
Primary outcomes included changes in:
Clinical periodontal parameters (PD, BOP, CAL) Tooth mobility (Periotest values) Masticatory performance indices OHIP-14 scores Secondary analyses examined correlations between masticatory performance and OHRQoL.
Statistical Analysis: Data distribution was assessed prior to analysis. Between-group comparisons were performed using ANOVA or Kruskal-Wallis tests, as appropriate. Within-group longitudinal changes were analyzed using repeated measures approaches. Spearman's rank correlation was used to evaluate associations between chewing efficiency and OHRQoL scores. Statistical significance was set at p < 0.05.
Scientific Rationale: This study addresses the multidimensional impact of periodontal rehabilitation beyond traditional clinical parameters. By integrating objective functional measurements and patient-reported outcomes, the research aims to clarify whether improvements in periodontal stability translate into meaningful gains in chewing efficiency and perceived well-being.
Understanding this relationship is important for patient-centered periodontal care and may contribute to more comprehensive treatment planning in advanced periodontitis.
- Conditions
- Periodontitis
- Being tested
- non-surgical periodontal treatment, surgical periodontal treatment
- Keywords
- periodontitis, periodontal therapy, mastication, quality of life
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal treatmentProcedure or surgery
non-surgical periodontal treatment
surgical periodontal treatmentProcedure or surgery
Periodontitis patients underwent surgical periodontal treatments.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal teratment | Active comparator | Periodontitis patients underwent both non-surgical and surgical periodontal treatments. Receives: Procedure: non-surgical periodontal treatment; Procedure: surgical periodontal treatment |
| Periodontal evaluation | No intervention | Both Healthy controls and periodontitis patients went through periodontal examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Plaque accumulation was assessed using a standardized plaque index at four sites per tooth. The presence of visible dental plaque along the gingival margin was recorded following gentle probing and air-drying when necessary. Scores were assigned according to established criteria (0 = no plaque; 1 = plaque detectable with probe; 2 = visible plaque; 3 = abundant plaque accumulation). Mean plaque index scores were calculated per participant to reflect overall oral hygiene status. Higher scores indicate greater plaque accumulation and poorer oral hygiene.
Measured: At Day 0, Day 30, Day 90
Probing depth
Probing depth was measured in millimeters using a calibrated periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, distolingual/palatal). The distance from the gingival margin to the base of the periodontal pocket was recorded. Measurements were rounded to the nearest millimeter. Mean probing depth values were calculated per participant. Greater probing depth values indicate more severe periodontal tissue destruction and disease severity.
Measured: At Day 0, Day 30, Day 90
Clinical attachment level
Clinical attachment level was measured in millimeters using a calibrated periodontal probe at six sites per tooth. CAL was calculated as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. In cases of gingival recession, the recession value was added to the probing depth; in cases of gingival enlargement, it was subtracted accordingly. Mean CAL values were calculated per participant. Higher CAL values indicate greater loss of periodontal attachment and increased disease severity.
Measured: At Day 0, Day 30, Day 90
Bleeding on probing
Bleeding on probing was assessed at six sites per tooth using a calibrated periodontal probe. After gentle probing of the sulcus or periodontal pocket, the presence or absence of bleeding within 15 seconds was recorded. BOP was expressed as the percentage of bleeding sites relative to the total number of sites examined per participant. Higher percentages indicate increased gingival inflammation and active periodontal disease.
Measured: At Day 0, Day 30, Day 90
Tooth mobility measurement
Tooth mobility was quantified using a Periotest M device (Medizintechnik Gulden, Modautal, Germany). Periotest values (PTVs) between +10 and +30 indicated Miller Class II, and between +30 and +50 Miller Class III mobility.
Measured: At Day 0, Day 30, Day 90
Masticatory performance
Masticatory efficiency was assessed using the silicone cube chewing test. Standardized cubes(8 × 8 × 8 mm) were prepared from Optosil® (Heraeus Kulzer, South Bend, IN, USA) using a plexiglass mold, sterilized in an autoclave, and weighed for standardization. Participants were instructed to chew eight cubes for 20 cycles while seated upright. The procedure was visually monitored by the examiner and recorded on video to verify the number of cycles. The chewed material was collected, rinsed, and dried at room temperature for three days before analysis. Chewed samples were analyzed using a multiple-sieve system with apertures of 4.0, 2.0, 1.0, 0.5, and 0.25 mm (in accordance with the ISO standard). The participant rinsed their mouth with water to remove residual particles, expelling them into the same receptacles. The particles were washed with water, allowed to dry, and removed from the paper filter. The median particle size was calculated from the cumulative weight distribution.
Measured: At Day 0, Day 30, Day 90
Secondary outcomes (1)
Assessment of oral health-related quality of life
The Turkish version of the Oral Health Impact Profile-14 (OHIP-14) was used to assess OHRQoL at baseline and post-treatment. Each item was scored on a five-point Likert scale (0 = never, 4 = very often), and total scores ranged from 0 to 56, with higher scores indicating a greater negative impact on quality of life.
Measured: At Day 0, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Dec 2019
- Primary completion1 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, controlled, longitudinal interventional study included a periodontitis group and a healthy control group. Patients diagnosed with Stage III, Grade B periodontitis received comprehensive periodontal therapy consisting of non-surgical treatment (scaling and root planing) followed by surgical therapy when indicated. All procedures were performed according to standard clinical guidelines. The periodontitis group was evaluated at three time points: baseline, after non-surgical therapy, and after surgical therapy. The healthy control group underwent a single baseline assessment and received no intervention. This within-subject longitudinal design allows assessment of treatment-related changes over time in clinical parameters, masticatory performance, and oral health-related quality of life. No randomization or blinding was applied; however, objective measurement tools were used to minimize assessment bias.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Guney, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450573
- Sponsor's protocol ID
- No. 36290600/45; 25 October 20
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available because of the participants consent.
Publications
Alkan A, Keskiner I, Arici S, Sato S. The effect of periodontitis on biting abilities. J Periodontol. 2006 Aug;77(8):1442-5. doi: 10.1902/jop.2006.060025.
PubMed 16881814von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007 Oct 16;147(8):573-7. doi: 10.7326/0003-4819-147-8-200710160-00010.
PubMed 17938396Solderer A, Kaufmann M, Hofer D, Wiedemeier D, Attin T, Schmidlin PR. Efficacy of chlorhexidine rinses after periodontal or implant surgery: a systematic review. Clin Oral Investig. 2019 Jan;23(1):21-32. doi: 10.1007/s00784-018-2761-y. Epub 2018 Dec 7.
PubMed 30535817Caffesse RG, Sweeney PL, Smith BA. Scaling and root planing with and without periodontal flap surgery. J Clin Periodontol. 1986 Mar;13(3):205-10. doi: 10.1111/j.1600-051x.1986.tb01461.x.
PubMed 3517073Pihlstrom BL, Ortiz-Campos C, McHugh RB. A randomized four-years study of periodontal therapy. J Periodontol. 1981 May;52(5):227-42. doi: 10.1902/jop.1981.52.5.227.
PubMed 7017103Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
PubMed 12787211Balci N, Alkan N, Gurgan CA. Psychometric properties of a Turkish version of the oral health impact profile-14. Niger J Clin Pract. 2017 Jan;20(1):19-24. doi: 10.4103/1119-3077.164353.
PubMed 27958241van der Bilt A, Fontijn-Tekamp FA. Comparison of single and multiple sieve methods for the determination of masticatory performance. Arch Oral Biol. 2004 Feb;49(2):155-60. doi: 10.1016/j.archoralbio.2003.08.004.
PubMed 14693210Pereira LJ, Gazolla CM, Magalhaes IB, Ramos-Jorge ML, Marques LS, Gameiro GH, Fonseca DC, Castelo PM. Treatment of chronic periodontitis and its impact on mastication. J Periodontol. 2011 Feb;82(2):243-50. doi: 10.1902/jop.2010.100178. Epub 2010 Jul 27.
PubMed 20653435Tonetti MS, Van Dyke TE; working group 1 of the joint EFP/AAP workshop*. Periodontitis and atherosclerotic cardiovascular disease: consensus report of the Joint EFP/AAPWorkshop on Periodontitis and Systemic Diseases. J Periodontol. 2013 Apr;84 Suppl 4S:S24-S29. doi: 10.1902/jop.2013.1340019.
PubMed 29537596van den Braber W, van der Bilt A, van der Glas HW, Bosman F, Rosenberg A, Koole R. The influence of orthognathic surgery on masticatory performance in retrognathic patients. J Oral Rehabil. 2005 Apr;32(4):237-41. doi: 10.1111/j.1365-2842.2004.01436.x.
PubMed 15790376
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periodontal Therapy on Function and Quality of Life in Stage III Periodontitis
- ClinicalTrials.gov ID
- NCT07450573
- Acronym / sponsor ID
- No. 36290600/45; 25 October 20
- Conditions
- Periodontitis
- Keywords
- periodontitis, periodontal therapy, mastication, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 4 Mar 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.
Stage III, Grade B periodontitis is a severe form of gum disease that damages the tissues and bone supporting the teeth. It can cause loose teeth, difficulty chewing, and reduced quality of life. Although periodontal (gum) treatment is known to improve gum health, less is known about how it affects chewing ability and how patients feel about their oral health after treatment.
This study looked at how comprehensive periodontal treatment affects gum health, chewing function, and oral health-related quality of life. Twenty patients with Stage III, Grade B periodontitis and twenty individuals with healthy gums participated. Patients with periodontitis received non-surgical treatment (deep cleaning and root surface debridement) followed, when needed, by surgical periodontal therapy.
Researchers measured gum health (including probing depth and bleeding), tooth mobility, chewing performance, and patient-reported quality of life. Chewing performance was tested using a standardized chewing test with silicone material. Quality of life was assessed using a validated questionnaire (OHIP-14), which measures how oral health affects daily life, comfort, and well-being.
Assessments were performed before treatment, after non-surgical therapy, and after surgical treatment.
At the start of the study, patients with periodontitis had worse gum health, poorer chewing ability, and lower oral health-related quality of life compared to healthy individuals. After treatment, gum inflammation and tooth mobility significantly improved. Chewing ability also improved after therapy, especially after surgical treatment. Patients reported better quality of life, with fewer symptoms and less discomfort.
The study also found that better chewing performance was strongly associated with better quality of life. This suggests that improving function is closely linked to how patients feel about their oral health.
Overall, comprehensive periodontal therapy not only improves clinical gum health but also enhances chewing efficiency and patient well-being. These findings highlight the functional and quality-of-life benefits of periodontal rehabilitation in patients with advanced gum disease.
Detailed description
Stage III, Grade B periodontitis is characterized by advanced periodontal attachment loss, deep periodontal pockets, tooth mobility, and radiographic bone loss. In addition to structural damage, this condition may impair masticatory efficiency and negatively affect oral health-related quality of life (OHRQoL). While conventional periodontal therapy effectively reduces inflammation and stabilizes periodontal tissues, its functional and patient-reported outcomes in advanced disease stages require further clarification.
This prospective controlled clinical study was designed to evaluate the impact of comprehensive periodontal therapy on clinical periodontal parameters, objective masticatory performance, and OHRQoL in patients with Stage III, Grade B periodontitis.
Study Population: The study included 20 systemically healthy patients diagnosed with Stage III, Grade B periodontitis and 20 periodontally healthy individuals serving as controls. Participants were recruited from a university dental clinic. Inclusion criteria for the periodontitis group were consistent with current periodontal classification guidelines. Exclusion criteria included systemic diseases affecting periodontal status, recent periodontal treatment, smoking, pregnancy, and use of medications known to influence periodontal tissues.
Study Design and Interventions: At baseline, all participants underwent comprehensive periodontal examination, including; Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL), Tooth mobility measured using Periotest. Masticatory performance was assessed using a standardized silicone cube chewing test. Participants chewed the test material for a defined number of cycles. The comminuted material was sieved through multiple apertures to calculate objective performance indices. OHRQoL was evaluated using the validated Oral Health Impact Profile (OHIP-14) questionnaire.
Patients in the periodontitis group received: Non-surgical periodontal therapy (scaling and root planing) and surgical periodontal therapy when indicated, following re-evaluation. Clinical and functional assessments were repeated after completion of non-surgical therapy and again following surgical treatment. The healthy control group was evaluated once for baseline comparison.
Outcome Measures:
Primary outcomes included changes in:
Clinical periodontal parameters (PD, BOP, CAL) Tooth mobility (Periotest values) Masticatory performance indices OHIP-14 scores Secondary analyses examined correlations between masticatory performance and OHRQoL.
Statistical Analysis: Data distribution was assessed prior to analysis. Between-group comparisons were performed using ANOVA or Kruskal-Wallis tests, as appropriate. Within-group longitudinal changes were analyzed using repeated measures approaches. Spearman's rank correlation was used to evaluate associations between chewing efficiency and OHRQoL scores. Statistical significance was set at p < 0.05.
Scientific Rationale: This study addresses the multidimensional impact of periodontal rehabilitation beyond traditional clinical parameters. By integrating objective functional measurements and patient-reported outcomes, the research aims to clarify whether improvements in periodontal stability translate into meaningful gains in chewing efficiency and perceived well-being.
Understanding this relationship is important for patient-centered periodontal care and may contribute to more comprehensive treatment planning in advanced periodontitis.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective, controlled, longitudinal interventional study included a periodontitis group and a healthy control group. Patients diagnosed with Stage III, Grade B periodontitis received comprehensive periodontal therapy consisting of non-surgical treatment (scaling and root planing) followed by surgical therapy when indicated. All procedures were performed according to standard clinical guidelines. The periodontitis group was evaluated at three time points: baseline, after non-surgical therapy, and after surgical therapy. The healthy control group underwent a single baseline assessment and received no intervention. This within-subject longitudinal design allows assessment of treatment-related changes over time in clinical parameters, masticatory performance, and oral health-related quality of life. No randomization or blinding was applied; however, objective measurement tools were used to minimize assessment bias.
| Arm | Type | Receives |
|---|---|---|
| Periodontal teratment | Active comparator | Procedure: non-surgical periodontal treatment, Procedure: surgical periodontal treatmentPeriodontitis patients underwent both non-surgical and surgical periodontal treatments. |
| Periodontal evaluation | No intervention | –Both Healthy controls and periodontitis patients went through periodontal examination. |
Who may qualify
- Ages
- 31 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ≥ 20 natural teeth
- at least four functional chewing units (one molar pair = two units; one premolar pair = one unit).
- positive bleeding on probing in ≥ four chewing units
- probing depth ≥ 5 mm in ≥ four molar or premolar teeth
- age between 20 and 45 years.
Key exclusion criteria (4 listed)
- Individuals with systemic diseases
- pregnancy
- smoking habits
- recent antibiotic or anti-inflammatory use
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 |
|---|---|---|
| non-surgical periodontal treatmentnon-surgical periodontal treatment | Procedure or surgery | Periodontal teratment |
| surgical periodontal treatmentPeriodontitis patients underwent surgical periodontal treatments. | Procedure or surgery | Periodontal teratment |
Primary outcome
Plaque index
Time frame: At Day 0, Day 30, Day 90
Plaque accumulation was assessed using a standardized plaque index at four sites per tooth. The presence of visible dental plaque along the gingival margin was recorded following gentle probing and air-drying when necessary. Scores were assigned according to established criteria (0 = no plaque; 1 = plaque detectable with probe; 2 = visible plaque; 3 = abundant plaque accumulation). Mean plaque index scores were calculated per participant to reflect overall oral hygiene status. Higher scores indicate greater plaque accumulation and poorer oral hygiene.
Probing depth
Time frame: At Day 0, Day 30, Day 90
Probing depth was measured in millimeters using a calibrated periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, distolingual/palatal). The distance from the gingival margin to the base of the periodontal pocket was recorded. Measurements were rounded to the nearest millimeter. Mean probing depth values were calculated per participant. Greater probing depth values indicate more severe periodontal tissue destruction and disease severity.
Clinical attachment level
Time frame: At Day 0, Day 30, Day 90
Clinical attachment level was measured in millimeters using a calibrated periodontal probe at six sites per tooth. CAL was calculated as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. In cases of gingival recession, the recession value was added to the probing depth; in cases of gingival enlargement, it was subtracted accordingly. Mean CAL values were calculated per participant. Higher CAL values indicate greater loss of periodontal attachment and increased disease severity.
Bleeding on probing
Time frame: At Day 0, Day 30, Day 90
Bleeding on probing was assessed at six sites per tooth using a calibrated periodontal probe. After gentle probing of the sulcus or periodontal pocket, the presence or absence of bleeding within 15 seconds was recorded. BOP was expressed as the percentage of bleeding sites relative to the total number of sites examined per participant. Higher percentages indicate increased gingival inflammation and active periodontal disease.
Tooth mobility measurement
Time frame: At Day 0, Day 30, Day 90
Tooth mobility was quantified using a Periotest M device (Medizintechnik Gulden, Modautal, Germany). Periotest values (PTVs) between +10 and +30 indicated Miller Class II, and between +30 and +50 Miller Class III mobility.
Masticatory performance
Time frame: At Day 0, Day 30, Day 90
Masticatory efficiency was assessed using the silicone cube chewing test. Standardized cubes(8 × 8 × 8 mm) were prepared from Optosil® (Heraeus Kulzer, South Bend, IN, USA) using a plexiglass mold, sterilized in an autoclave, and weighed for standardization. Participants were instructed to chew eight cubes for 20 cycles while seated upright. The procedure was visually monitored by the examiner and recorded on video to verify the number of cycles. The chewed material was collected, rinsed, and dried at room temperature for three days before analysis. Chewed samples were analyzed using a multiple-sieve system with apertures of 4.0, 2.0, 1.0, 0.5, and 0.25 mm (in accordance with the ISO standard). The participant rinsed their mouth with water to remove residual particles, expelling them into the same receptacles. The particles were washed with water, allowed to dry, and removed from the paper filter. The median particle size was calculated from the cumulative weight distribution.
1 secondary outcome
Assessment of oral health-related quality of life
Time frame: At Day 0, Day 30, Day 90
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 4 Mar 2026.
- Background: PubMed 16881814Alkan A, Keskiner I, Arici S, Sato S. The effect of periodontitis on biting abilities. J Periodontol. 2006 Aug;77(8):1442-5. doi: 10.1902/jop.2006.060025.
- Background: PubMed 17938396von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007 Oct 16;147(8):573-7. doi: 10.7326/0003-4819-147-8-200710160-00010.
- Background: PubMed 30535817Solderer A, Kaufmann M, Hofer D, Wiedemeier D, Attin T, Schmidlin PR. Efficacy of chlorhexidine rinses after periodontal or implant surgery: a systematic review. Clin Oral Investig. 2019 Jan;23(1):21-32. doi: 10.1007/s00784-018-2761-y. Epub 2018 Dec 7.
- Background: PubMed 3517073Caffesse RG, Sweeney PL, Smith BA. Scaling and root planing with and without periodontal flap surgery. J Clin Periodontol. 1986 Mar;13(3):205-10. doi: 10.1111/j.1600-051x.1986.tb01461.x.
- Background: PubMed 7017103Pihlstrom BL, Ortiz-Campos C, McHugh RB. A randomized four-years study of periodontal therapy. J Periodontol. 1981 May;52(5):227-42. doi: 10.1902/jop.1981.52.5.227.
- Background: PubMed 12787211Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
- Background: PubMed 27958241Balci N, Alkan N, Gurgan CA. Psychometric properties of a Turkish version of the oral health impact profile-14. Niger J Clin Pract. 2017 Jan;20(1):19-24. doi: 10.4103/1119-3077.164353.
- Background: PubMed 14693210van der Bilt A, Fontijn-Tekamp FA. Comparison of single and multiple sieve methods for the determination of masticatory performance. Arch Oral Biol. 2004 Feb;49(2):155-60. doi: 10.1016/j.archoralbio.2003.08.004.
- Background: PubMed 20653435Pereira LJ, Gazolla CM, Magalhaes IB, Ramos-Jorge ML, Marques LS, Gameiro GH, Fonseca DC, Castelo PM. Treatment of chronic periodontitis and its impact on mastication. J Periodontol. 2011 Feb;82(2):243-50. doi: 10.1902/jop.2010.100178. Epub 2010 Jul 27.
- Background: PubMed 29537596Tonetti MS, Van Dyke TE; working group 1 of the joint EFP/AAP workshop*. Periodontitis and atherosclerotic cardiovascular disease: consensus report of the Joint EFP/AAPWorkshop on Periodontitis and Systemic Diseases. J Periodontol. 2013 Apr;84 Suppl 4S:S24-S29. doi: 10.1902/jop.2013.1340019.
- Background: PubMed 15790376van den Braber W, van der Bilt A, van der Glas HW, Bosman F, Rosenberg A, Koole R. The influence of orthognathic surgery on masticatory performance in retrognathic patients. J Oral Rehabil. 2005 Apr;32(4):237-41. doi: 10.1111/j.1365-2842.2004.01436.x.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available because of the participants consent.
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Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 non-surgical periodontal treatment and surgical periodontal treatment in people with Periodontitis, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
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 4 Mar 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 Turkey (Türkiye). 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?
Plaque index (time frame: At Day 0, Day 30, Day 90). The study lists 6 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 NCT07450573, which also lists 11 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 4 Mar 2026.