Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

Not Applicable

Completed

• Conditions: Periodontal; Lesion; Periodontal Attachment Loss; Periodontitis
• Interventions: Procedure: Subgingival Debridement

• Registration Number: NCT03098498
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-03-31
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Results First Submitted: 2022-06-01
• Results First Submitted QC: 2024-05-22
• Results First Posted: 2024-09-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two-Stage Subgingival Debridement	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
One-Stage Subgingival Debridement	Subgingival Debridement	Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing

Primary Outcome Measures

Name	Time	Method
Change in Clinical Attachment Loss	168 days (24 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Change in Bleeding on Probing	168 days (24 weeks)	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.
Change in Probing Pocket Depth	168 days (24 weeks)	Difference in probing pocket depth between baseline and end of study in teeth with a baseline periodontal probing pocket depth ≥ 6 mm
Change in Gingival Index (GI)	168 days (24 weeks)	Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study
Change in Plaque Index	168 days (24 weeks)	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

Trial Locations

Locations (1)

Dept. of Periodontology, University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany