Impact of Periodontal Therapy on Function and Quality of Life in Stage III Periodontitis

NCT07450573 | Completed

• 1 other identifier: No. 36290600/45; 25 October 20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontitis

Keywords

periodontitis; periodontal therapy; mastication; quality of life

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  At Day 0, Day 30, Day 90

Secondary Outcomes (1)

• Assessment of oral health-related quality of life

  At Day 0, Day 30, Day 90

Study Arms (2)

Periodontal teratment

ACTIVE COMPARATOR

Periodontitis patients underwent both non-surgical and surgical periodontal treatments.

Procedure: non-surgical periodontal treatment; Procedure: surgical periodontal treatment

Periodontal evaluation

NO INTERVENTION

Both Healthy controls and periodontitis patients went through periodontal examination.

Interventions

non-surgical periodontal treatment PROCEDURE

non-surgical periodontal treatment

Periodontal teratment

surgical periodontal treatment PROCEDURE

Periodontitis patients underwent surgical periodontal treatments.

Periodontal teratment

Eligibility Criteria

• Age: 31 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 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.

You may not qualify if:

• Individuals with systemic diseases
• pregnancy
• smoking habits
• recent antibiotic or anti-inflammatory use

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Ankara Medipol University

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (11)

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  PMID: 16881814 BACKGROUND

• 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.

  PMID: 17938396 BACKGROUND

• 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.

  PMID: 30535817 BACKGROUND

• 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.

  PMID: 3517073 BACKGROUND

• 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.

  PMID: 7017103 BACKGROUND

• 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.

  PMID: 12787211 BACKGROUND

• 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.

  PMID: 27958241 BACKGROUND

• 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.

  PMID: 14693210 BACKGROUND

• 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.

  PMID: 20653435 BACKGROUND

• 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.

  PMID: 29537596 BACKGROUND

• 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.

  PMID: 15790376 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: March 4, 2026
• Study Start: December 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 5, 2021
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)