Skip to main content
OpenTrials
Completed

NCT Number: NCT04646265

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

Bonn, North Rhine-Westphalia, 53111, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal treatment

Other

non-surgical root debridement

Primary outcomes

  1. Probing depth (PPD) at test tooth

    Time frame: 3 months

    mean PPD (mm)

  2. Bleeding on Probing (BoP)

    Time frame: 3 months

    mean BoP (%)

  3. Clinical attachment level (CAL)

    Time frame: 3 months

    mean attachment level (mm)

  4. Biomechanical analysis

    Time frame: 3 months

    Tooth displacement (mm)

Secondary outcomes

  1. Biotype/keratinized tissue width (KT)

    Time frame: 3 months

    mean - keratinized tissue width (KT)

  2. 1.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Limit the kinds of food - Questionaire by visual analogue scale (VAS)

  3. 2.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Trouble biting or chewing - Questionaire by visual analogue scale (VAS)

  4. 3.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Problems to swallow comfortably - Questionaire by visual analogue scale (VAS)

  5. 4.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Problems to speak clearly - Questionaire by visual analogue scale (VAS)

  6. 5.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Discomfort when eating any kind of food - Questionaire by visual analogue scale (VAS)

  7. 6.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Limit contact with people - Questionaire by visual analogue scale (VAS)

  8. 7.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Pleased with look of teeth- Questionaire by visual analogue scale (VAS)

  9. 8.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Used medication to relieve pain- Questionaire by visual analogue scale (VAS)

  10. 9.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Worried about teeth, gums or dentures - Questionaire by visual analogue scale (VAS)

  11. 10.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Self-conscious of teeth, gums or dentures - Questionaire by visual analogue scale (VAS)

  12. 11.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Uncomfortable eating in front of others - Questionaire by visual analogue scale (VAS)

  13. 12.General Oral Health Assessments Indices (GOHAI)

    Time frame: 3 months

    Sensitive to hot, cold or sweet foods - Questionaire by visual analogue scale (VAS)

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Registry information

Official study title

The Effect of Non-surgical Periodontal Treatment on the Biomechanical Properties of the Periodontal Tissues, a Prospective Comparative Clinical Trial.

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Nov 27, 2020
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.