Effect of Periodontal Treatment on the Biomechanical Properties of the Periodontium.

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: periodontal treatment

• Registration Number: NCT04646265
• Lead Sponsor: University of Bonn

Brief Summary

Investigation of the biomechanical properties of the periodontal tissues in patients with periodontal disease. Non-surgical periodontal therapy will be assessed between baseline and 30 post-op by general clinical measurements (KT, PPD, CAL, BOP) as well as by biomechanical analysis and compared.

Detailed Description

The study is designed as a prospective single center comparative clinical trial to investigate the biomechanical properties of the periodontal tissues in 30 patients with periodontal disease.

Success of non-surgical periodontal therapy between baseline and 30 post-op will be assessed by general clinical measurements (KT, PD, CAL, BOP) as well as by biomechanical analysis. Besides assessment for regular treatment effectiveness, safety parameter such as wound healing and adverse events will be assessed.

Additionally 10 periodontally healthy persons without local inflammation and bone loss shall be monitored and used a control group for reference to the test teeth.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-22
• Study First Posted: 2020-11-27
• Primary Completion: 2020-12-01
• Study Completion: 2022-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Moderate/advanced/severe periodontitis
• Intact anterior dentition upper yaw.
• Expected performance of adequate oral hygiene
• Subjects must have voluntarily signed the informed consent form before any study related procedures
• Males and females with at least 18 years of age
• Subjects must be committed to the study and the required follow-up visits
• Subject must be judged in good general health as assessed by the investigator at time of non-surgical therapy

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Exclusion Criteria

• Any contraindications for subgingival instrumentation
• Uncontrolled diabetes or other uncontrolled systemic diseases
• Disorders or treatments that compromise wound healing
• Medical conditions requiring chronic high dose steroid therapy
• Bone metabolic diseases
• Radiation or other immuno-oppressive therapy
• Chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to treatment
• Presence of oral lesions (such as ulceration, malignancy)
• Mucosal diseases (e.g., lichen planus, mouth ulcer)
• History of malignant disease in the oral cavity or previous radiotherapy to the head or neck
• Treatment with an investigational drug or device within the 30 day period immediately prior to therapy on study day 0
• Female subjects who are nursing, pregnant, or plan to become pregnant
• Antibiotic treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
periodontal treatment	periodontal treatment	non-surgical root debridement

Primary Outcome Measures

Name	Time	Method
Probing depth (PPD) at test tooth	3 months	mean PPD (mm)
Biomechanical analysis	3 months	Tooth displacement (mm)
Clinical attachment level (CAL)	3 months	mean attachment level (mm)
Bleeding on Probing (BoP)	3 months	mean BoP (%)

Secondary Outcome Measures

Name	Time	Method
3.General Oral Health Assessments Indices (GOHAI)	3 months	Problems to swallow comfortably - Questionaire by visual analogue scale (VAS)
7.General Oral Health Assessments Indices (GOHAI)	3 months	Pleased with look of teeth- Questionaire by visual analogue scale (VAS)
2.General Oral Health Assessments Indices (GOHAI)	3 months	Trouble biting or chewing - Questionaire by visual analogue scale (VAS)
4.General Oral Health Assessments Indices (GOHAI)	3 months	Problems to speak clearly - Questionaire by visual analogue scale (VAS)
5.General Oral Health Assessments Indices (GOHAI)	3 months	Discomfort when eating any kind of food - Questionaire by visual analogue scale (VAS)
1.General Oral Health Assessments Indices (GOHAI)	3 months	Limit the kinds of food - Questionaire by visual analogue scale (VAS)
6.General Oral Health Assessments Indices (GOHAI)	3 months	Limit contact with people - Questionaire by visual analogue scale (VAS)
10.General Oral Health Assessments Indices (GOHAI)	3 months	Self-conscious of teeth, gums or dentures - Questionaire by visual analogue scale (VAS)
Biotype/keratinized tissue width (KT)	3 months	mean - keratinized tissue width (KT)
8.General Oral Health Assessments Indices (GOHAI)	3 months	Used medication to relieve pain- Questionaire by visual analogue scale (VAS)
11.General Oral Health Assessments Indices (GOHAI)	3 months	Uncomfortable eating in front of others - Questionaire by visual analogue scale (VAS)
9.General Oral Health Assessments Indices (GOHAI)	3 months	Worried about teeth, gums or dentures - Questionaire by visual analogue scale (VAS)
12.General Oral Health Assessments Indices (GOHAI)	3 months	Sensitive to hot, cold or sweet foods - Questionaire by visual analogue scale (VAS)

Trial Locations

Locations (1)

Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde; 🇩🇪 Bonn, North Rhine-Westphalia, Germany