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

University of Bonn

Status

Completed

Conditions

Periodontal Diseases

Treatments

Other: periodontal treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04646265

Ethik Nr.030/12

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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