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

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ClinicalTrials.gov Identifier: NCT04646265

Recruitment Status : Active, not recruiting

First Posted : November 27, 2020

Last Update Posted : November 27, 2020

Sponsor:

Information provided by (Responsible Party):

Karin Jepsen, University of Bonn

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periodontal Diseases	Other: periodontal treatment	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	prospective single center comparative clinical trial to investigate the biomechanical properties of periodontal tissues
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	The Effect of Non-surgical Periodontal Treatment on the Biomechanical Properties of the Periodontal Tissues, a Prospective Comparative Clinical Trial.
Actual Study Start Date :	October 1, 2017
Estimated Primary Completion Date :	December 1, 2020
Estimated Study Completion Date :	February 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: periodontal treatment non-surgical root debridement	Other: periodontal treatment non-surgical root debridement

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646265

Locations

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

Sponsors and Collaborators

University of Bonn

Investigators

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Principal Investigator:	Søren Jepsen, PhD	University of Bonn

More Information

Publications of Results:

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, Jäger 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. Review.

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.

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. Review.

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Responsible Party:	Karin Jepsen, Associated Professor, University of Bonn
ClinicalTrials.gov Identifier:	NCT04646265
Other Study ID Numbers:	Ethik Nr.030/12
First Posted:	November 27, 2020 Key Record Dates
Last Update Posted:	November 27, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Karin Jepsen, University of Bonn:


Biomechanics non-surgical periodontal treatment

Additional relevant MeSH terms:

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Periodontal Diseases Mouth Diseases Stomatognathic Diseases

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