- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450573
Impact of Periodontal Therapy on Function and Quality of Life in Stage III Periodontitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06010
- Ankara Medipol University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Eligibility criteria included
- ≥ 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.
Exclusion Criteria:
- Individuals with systemic diseases
- pregnancy
- smoking habits
- recent antibiotic or anti-inflammatory use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Periodontal teratment
Periodontitis patients underwent both non-surgical and surgical periodontal treatments.
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non-surgical periodontal treatment
Periodontitis patients underwent surgical periodontal treatments.
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No Intervention: Periodontal evaluation
Both Healthy controls and periodontitis patients went through periodontal examination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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At Day 0, Day 30, Day 90
|
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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.
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At Day 0, Day 30, Day 90
|
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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.
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At Day 0, Day 30, Day 90
|
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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.
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At Day 0, Day 30, Day 90
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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.
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At Day 0, Day 30, Day 90
|
|
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.
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At Day 0, Day 30, Day 90
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of oral health-related quality of life
Time Frame: At Day 0, Day 30, Day 90
|
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.
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At Day 0, Day 30, Day 90
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Heitz-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.
- Solderer 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.
- von 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.
- 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.
- Caffesse 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.
- Pihlstrom 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.
- Balci 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.
- van 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.
- Pereira 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.
- Tonetti 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.
- van 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 36290600/45; 25 October 20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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