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

NCT04646265 | Completed

• 1 other identifier: Ethik Nr.030/12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

Biomechanics; non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Biotype/keratinized tissue width (KT)

  3 months

• 1.General Oral Health Assessments Indices (GOHAI)

  3 months

• 2.General Oral Health Assessments Indices (GOHAI)

  3 months

• 3.General Oral Health Assessments Indices (GOHAI)

  3 months

• 4.General Oral Health Assessments Indices (GOHAI)

  3 months

Study Arms (1)

periodontal treatment

EXPERIMENTAL

non-surgical root debridement

Other: periodontal treatment

Interventions

periodontal treatment OTHER

non-surgical root debridement

periodontal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (1)

Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

Bonn, North Rhine-Westphalia, 53111, Germany

Location

Related 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 28;44(11):2136-43. doi: 10.1016/j.jbiomech.2011.05.025. Epub 2011 Jun 15.

  PMID: 21679952 RESULT

• 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.

  PMID: 26395824 RESULT

• 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.

  PMID: 32299416 RESULT

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

  PMID: 25534621 RESULT

• 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.

  PMID: 11719079 RESULT

• 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.

  PMID: 21134234 RESULT

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Søren Jepsen, PhD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: prospective single center comparative clinical trial to investigate the biomechanical properties of periodontal tissues

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 27, 2020
• Study Start: October 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)