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

Periodontal Diseases Clinical Trial

Official title:

The Effect of Non-surgical Periodontal Treatment on the Biomechanical Properties of the Periodontal Tissues, a Prospective Comparative Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646265
• Other study ID #: Ethik Nr.030/12
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: University of Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• periodontal treatment
non-surgical root debridement

Locations

Country	Name	City	State
Germany	Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde	Bonn	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University of Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Drolshagen M, Keilig L, Hasan I, Reimann S, Deschner J, Brinkmann KT, Krause R, Favino M, Bourauel C. Development of a novel intraoral measurement device to determine the biomechanical characteristics of the human periodontal ligament. J Biomech. 2011 Jul — View Citation

Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785. — View Citation

Jepsen S, Deschner J, Braun A, Schwarz F, Eberhard J. Calculus removal and the prevention of its formation. Periodontol 2000. 2011 Feb;55(1):167-88. doi: 10.1111/j.1600-0757.2010.00382.x. No abstract available. — View Citation

Keilig L, Drolshagen M, Tran KL, Hasan I, Reimann S, Deschner J, Brinkmann KT, Krause R, Favino M, Bourauel C. In vivo measurements and numerical analysis of the biomechanical characteristics of the human periodontal ligament. Ann Anat. 2016 Jul;206:80-8. — View Citation

Keilig L, Goedecke J, Bourauel C, Daratsianos N, Dirk C, Jager A, Konermann A. Increased tooth mobility after fixed orthodontic appliance treatment can be selectively utilized for case refinement via positioner therapy - a pilot study. BMC Oral Health. 20 — View Citation

Yoshida N, Koga Y, Peng CL, Tanaka E, Kobayashi K. In vivo measurement of the elastic modulus of the human periodontal ligament. Med Eng Phys. 2001 Oct;23(8):567-72. doi: 10.1016/s1350-4533(01)00073-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth (PPD) at test tooth	mean PPD (mm)	3 months
Primary	Bleeding on Probing (BoP)	mean BoP (%)	3 months
Primary	Clinical attachment level (CAL)	mean attachment level (mm)	3 months
Primary	Biomechanical analysis	Tooth displacement (mm)	3 months
Secondary	Biotype/keratinized tissue width (KT)	mean - keratinized tissue width (KT)	3 months
Secondary	1.General Oral Health Assessments Indices (GOHAI)	Limit the kinds of food - Questionaire by visual analogue scale (VAS)	3 months
Secondary	2.General Oral Health Assessments Indices (GOHAI)	Trouble biting or chewing - Questionaire by visual analogue scale (VAS)	3 months
Secondary	3.General Oral Health Assessments Indices (GOHAI)	Problems to swallow comfortably - Questionaire by visual analogue scale (VAS)	3 months
Secondary	4.General Oral Health Assessments Indices (GOHAI)	Problems to speak clearly - Questionaire by visual analogue scale (VAS)	3 months
Secondary	5.General Oral Health Assessments Indices (GOHAI)	Discomfort when eating any kind of food - Questionaire by visual analogue scale (VAS)	3 months
Secondary	6.General Oral Health Assessments Indices (GOHAI)	Limit contact with people - Questionaire by visual analogue scale (VAS)	3 months
Secondary	7.General Oral Health Assessments Indices (GOHAI)	Pleased with look of teeth- Questionaire by visual analogue scale (VAS)	3 months
Secondary	8.General Oral Health Assessments Indices (GOHAI)	Used medication to relieve pain- Questionaire by visual analogue scale (VAS)	3 months
Secondary	9.General Oral Health Assessments Indices (GOHAI)	Worried about teeth, gums or dentures - Questionaire by visual analogue scale (VAS)	3 months
Secondary	10.General Oral Health Assessments Indices (GOHAI)	Self-conscious of teeth, gums or dentures - Questionaire by visual analogue scale (VAS)	3 months
Secondary	11.General Oral Health Assessments Indices (GOHAI)	Uncomfortable eating in front of others - Questionaire by visual analogue scale (VAS)	3 months
Secondary	12.General Oral Health Assessments Indices (GOHAI)	Sensitive to hot, cold or sweet foods - Questionaire by visual analogue scale (VAS)	3 months