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Periodontal DiseasesNCT04646265

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

A study testing periodontal treatment in people with Periodontal Diseases, run by University of Bonn at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
periodontal treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
1 Oct 2017to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

    Bonn, North Rhine-Westphalia, 53111

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
periodontal treatment
Keywords
Biomechanics, non-surgical periodontal treatment
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • periodontal treatmentOther

    non-surgical root debridement

Study groups in NCT04646265
Study groupRoleWhat they receive
periodontal treatmentExperimentalnon-surgical root debridement
Receives: Other: periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probing depth (PPD) at test tooth

    mean PPD (mm)

    Measured: 3 months

  2. Bleeding on Probing (BoP)

    mean BoP (%)

    Measured: 3 months

  3. Clinical attachment level (CAL)

    mean attachment level (mm)

    Measured: 3 months

  4. Biomechanical analysis

    Tooth displacement (mm)

    Measured: 3 months

Secondary outcomes (13)

  1. Biotype/keratinized tissue width (KT)

    mean - keratinized tissue width (KT)

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study start1 Oct 2017
  3. Primary completion1 Dec 2020
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
prospective single center comparative clinical trial to investigate the biomechanical properties of periodontal tissues
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04646265
Sponsor's protocol ID
Ethik Nr.030/12
Status last verified
Mar 2023
First submitted
14 Nov 2020
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21679952

  • 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.

    PubMed 26395824

  • 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.

    PubMed 32299416

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

    PubMed 25534621

  • 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.

    PubMed 11719079

  • 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.

    PubMed 21134234

Questions about this trial

What is this clinical trial studying?

A study testing periodontal treatment in people with Periodontal Diseases, run by University of Bonn at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probing depth (PPD) at test tooth (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646265, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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