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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Other: periodontal treatment

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53111
      • Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periodontal treatment; non-surgical root debridement	Other: periodontal treatment; non-surgical root debridement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bonn
• Investigators: Principal Investigator: Søren Jepsen, PhD, University of Bonn

Publications and helpful links

General Publications

• 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 28;44(11):2136-43. doi: 10.1016/j.jbiomech.2011.05.025. Epub 2011 Jun 15.
• 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. doi: 10.1016/j.aanat.2015.08.004. Epub 2015 Sep 12.
• 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. 2020 Apr 16;20(1):114. doi: 10.1186/s12903-020-01097-4.
• Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Biomechanics; non-surgical periodontal treatment
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: Ethik Nr.030/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No