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

Primary Purpose

Periodontitis, Periodontal Attachment Loss, Periodontal; Lesion

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Subgingival Debridement
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, scaling, attachment gain, air polishing, periodontal lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Periodontology, University Hospital WuerzburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Two-Stage Subgingival Debridement

One-Stage Subgingival Debridement

Arm Description

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

Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing

Outcomes

Primary Outcome Measures

Reduction of Clinical Attachment Loss
Measuring the distance between the cemento-enamel-junction and the probeable bottom of the periodontal pocket

Secondary Outcome Measures

Bleeding on Probing
Recording the possible appearance of a bleeding spot immediately after the probing of periodontal lesions for the measurement of clinical attachment loss
Probing Pocket Depth
Measuring the distance between the gingival sulcus and the bottom of the periodontal lesion
Gingival Index
Visual Assessment of the inflammatory status of the gingiva according to the criteria set by Lobene et al.
Plaque Index
Measuring the extent of supragingival plaque coverage according to the criteria set by Silness and Loe

Full Information

First Posted
March 27, 2017
Last Updated
March 30, 2017
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03098498
Brief Title
Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
Acronym
ATTGAIN16
Official Title
Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Attachment Loss, Periodontal; Lesion
Keywords
periodontitis, scaling, attachment gain, air polishing, periodontal lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
controlled prospective parallel group intervention trial
Masking
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.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-Stage Subgingival Debridement
Arm Type
Experimental
Arm Description
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
Arm Title
One-Stage Subgingival Debridement
Arm Type
Active Comparator
Arm Description
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
Subgingival Debridement
Other Intervention Name(s)
Scaling and Root Planing
Intervention Description
Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
Primary Outcome Measure Information:
Title
Reduction of Clinical Attachment Loss
Description
Measuring the distance between the cemento-enamel-junction and the probeable bottom of the periodontal pocket
Time Frame
168 days (24 weeks)
Secondary Outcome Measure Information:
Title
Bleeding on Probing
Description
Recording the possible appearance of a bleeding spot immediately after the probing of periodontal lesions for the measurement of clinical attachment loss
Time Frame
168 days (24 weeks)
Title
Probing Pocket Depth
Description
Measuring the distance between the gingival sulcus and the bottom of the periodontal lesion
Time Frame
168 days (24 weeks)
Title
Gingival Index
Description
Visual Assessment of the inflammatory status of the gingiva according to the criteria set by Lobene et al.
Time Frame
168 days (24 weeks)
Title
Plaque Index
Description
Measuring the extent of supragingival plaque coverage according to the criteria set by Silness and Loe
Time Frame
168 days (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Schlagenhauf, Prof. Dr.
Phone
04993147083138
Email
schlagenha_u@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jockel-Schneider, Yvonne, Dr.
Phone
004993147083138
Email
Jockel_Y@zahnklinik.uni-wuerzburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Schlagenhauf, Prof. Dr.
Organizational Affiliation
Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Periodontology, University Hospital Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Schlagenhauf, Prof. Dr.
Phone
49-931-201
Ext
72630
Email
schlagenha_u@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

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