Clinical trial NCT04646265: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Biomechanics
non-surgical periodontal treatment
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective single center comparative clinical trial to investigate the biomechanical properties of periodontal tissues
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Probing depth (PPD) at test tooth
timeFrame: 3 months
measure: Bleeding on Probing (BoP)
timeFrame: 3 months
measure: Clinical attachment level (CAL)
timeFrame: 3 months
measure: Biomechanical analysis
timeFrame: 3 months
Secondary outcomes:
measure: Biotype/keratinized tissue width (KT)
timeFrame: 3 months
measure: 1.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 2.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 3.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 4.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 5.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 6.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 7.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 8.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 9.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 10.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 11.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
measure: 12.General Oral Health Assessments Indices (GOHAI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde
state: North Rhine-Westphalia
Study officials:
affiliation: University of Bonn
name: Søren Jepsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
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.
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.