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NCT Number: 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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

31 year–51 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Medipol University

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

non-surgical periodontal treatment

Surgical Periodontal Treatment

Procedure

Periodontitis patients underwent surgical periodontal treatments.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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