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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Attachment Loss; Periodontal; Lesion
• Intervention / Treatment: Procedure: Subgingival Debridement

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97070
    • Dept. of Periodontology, University Hospital Wuerzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Scaling and Root Planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Attachment Loss	Difference in millimeter (mm) in the distance between the cemento-enamel-junction and the probable bottom of the periodontal pocket recorded at baseline and at the end of the study in periodontal pockets with a baseline pocket depth ≥ 6 mm	168 days (24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bleeding on Probing	Difference in the mean percentage of probed periodontal probing sites in teeth with initial pocket depth ≥ 6 mm displaying bleeding on probing between baseline and end of the study.	168 days (24 weeks)
Change in Probing Pocket Depth	Difference in probing pocket depth between baseline and end of study in teeth with a baseline periodontal probing pocket depth ≥ 6 mm	168 days (24 weeks)
Change in Gingival Index (GI)	Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study	168 days (24 weeks)
Change in Plaque Index	Measuring the difference in the extent of supragingival plaque coverage according to the criteria set by Silness and Loe between baseline and end of study	168 days (24 weeks)

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Ulrich Schlagenhauf, Prof. Dr., Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: periodontitis; air polishing; scaling; attachment gain; periodontal lesion
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Attachment Loss
• Other Study ID Numbers: WuerzburgUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No