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Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy (ATTGAIN16)

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ClinicalTrials.gov Identifier: NCT03098498
Recruitment Status : Unknown
Verified March 2017 by Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital.
Recruitment status was:  Recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital

Brief Summary:
This study compared the gain of periodontal attachment after concomitant one-stage removal of bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.

Condition or disease Intervention/treatment Phase
Periodontitis Periodontal Attachment Loss Periodontal; Lesion Procedure: Subgingival Debridement Not Applicable

Detailed Description:
The concomitant removal of subgingival calculus and soft bacterial biofilms in a one-stage procedure might impair periodontal healing in deep infrabony pockets due to the mechanical disruption of demineralized bone sections at the bottom of periodontal lesions. This randomized controlled clinical trial therefore aims at comparing the resulting attachment gain 6 months after one-stage antiinfective periodontal therapy comprising the concomitant subgingival removal of soft bacterial biofilms and calculus with a two-stage approach removing subgingival calculus only 6 weeks after the initial removal of soft subgingival bacterial biofilms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: controlled prospective parallel group intervention trial
Masking: Single (Outcomes Assessor)
Masking Description: The examiner performing the assessment of periodontal attachment gain is not aware of the type of the preceding intervention therapy (one-stage vs. two-stage) provided to the patient.
Primary Purpose: Treatment
Official Title: Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2017

Arm Intervention/treatment
Experimental: Two-Stage Subgingival Debridement
Initially soft subgingival bacterial biofilms are removed from periodontal lesions by an airpolishing device and erythritol cleaning powder. 6 weeks later subgingival calculus is mechanically removed in a second step by mechanical scaling and root planing
Procedure: Subgingival Debridement
Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
Other Name: Scaling and Root Planing

Active Comparator: One-Stage Subgingival Debridement
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Procedure: Subgingival Debridement
Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
Other Name: Scaling and Root Planing




Primary Outcome Measures :
  1. Reduction of Clinical Attachment Loss [ Time Frame: 168 days (24 weeks) ]
    Measuring the distance between the cemento-enamel-junction and the probeable bottom of the periodontal pocket


Secondary Outcome Measures :
  1. Bleeding on Probing [ Time Frame: 168 days (24 weeks) ]
    Recording the possible appearance of a bleeding spot immediately after the probing of periodontal lesions for the measurement of clinical attachment loss

  2. Probing Pocket Depth [ Time Frame: 168 days (24 weeks) ]
    Measuring the distance between the gingival sulcus and the bottom of the periodontal lesion

  3. Gingival Index [ Time Frame: 168 days (24 weeks) ]
    Visual Assessment of the inflammatory status of the gingiva according to the criteria set by Lobene et al.

  4. Plaque Index [ Time Frame: 168 days (24 weeks) ]
    Measuring the extent of supragingival plaque coverage according to the criteria set by Silness and Loe



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of periodontal disease
  • minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
  • minimum of 15 natural teeth

Exclusion Criteria:

  • systemic disease interfering with periodontal healing (e.g. diabetes)
  • antibiotic therapy ≤ 12 month prior to study participation
  • necessity for preventive antibiotic therapy during dental interventions
  • inability to comply with the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098498


Contacts
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Contact: Ulrich Schlagenhauf, Prof. Dr. 04993147083138 schlagenha_u@ukw.de
Contact: Jockel-Schneider, Yvonne, Dr. 004993147083138 Jockel_Y@zahnklinik.uni-wuerzburg.de

Locations
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Germany
Dept. of Periodontology, University Hospital Wuerzburg Recruiting
Wuerzburg, Germany, 97070
Contact: Ulrich Schlagenhauf, Prof. Dr.    49-931-201 ext 72630    schlagenha_u@ukw.de   
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Ulrich Schlagenhauf, Prof. Dr. Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany

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Responsible Party: Prof. Dr. Ulrich Schlagenhauf, Chairman Dept. of Periodontology, Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03098498     History of Changes
Other Study ID Numbers: WuerzburgUH
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital:
periodontitis
scaling
attachment gain
air polishing
periodontal lesion

Additional relevant MeSH terms:
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Periodontitis
Periodontal Attachment Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Anti-Infective Agents