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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
periodontal treatment
Sponsored by
University of Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Periodontal Diseases focused on measuring Biomechanics, non-surgical periodontal treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

periodontal treatment

Arm Description

non-surgical root debridement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2020
Last Updated
March 27, 2023
Sponsor
University of Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT04646265
Brief Title
Effect of Periodontal Treatment on the Biomechanical Properties of the Periodontium.
Official Title
The Effect of Non-surgical Periodontal Treatment on the Biomechanical Properties of the Periodontal Tissues, a Prospective Comparative Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bonn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Biomechanics, non-surgical periodontal treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective single center comparative clinical trial to investigate the biomechanical properties of periodontal tissues
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Jepsen, PhD
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde
City
Bonn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
53111
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21679952
Citation
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.
Results Reference
result
PubMed Identifier
26395824
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. doi: 10.1016/j.aanat.2015.08.004. Epub 2015 Sep 12.
Results Reference
result
PubMed Identifier
32299416
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. 2020 Apr 16;20(1):114. doi: 10.1186/s12903-020-01097-4.
Results Reference
result
PubMed Identifier
25534621
Citation
Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
Results Reference
result
PubMed Identifier
11719079
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.
Results Reference
result
PubMed Identifier
21134234
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.
Results Reference
result

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

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