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: Unknown
• 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 (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulrich Schlagenhauf, Prof. Dr.; Phone Number: 04993147083138; Email: schlagenha_u@ukw.de
• Study Contact Backup: Name: Jockel-Schneider, Yvonne, Dr.; Phone Number: 004993147083138; Email: Jockel_Y@zahnklinik.uni-wuerzburg.de

Study Locations

• Germany
  • Wuerzburg, Germany, 97070
    • Recruiting
    • Dept. of Periodontology, University Hospital Wuerzburg
    • Contact: Ulrich Schlagenhauf, Prof. Dr.; Phone Number: 72630 49-931-201; Email: schlagenha_u@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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
Reduction of Clinical Attachment Loss	Measuring the distance between the cemento-enamel-junction and the probeable bottom of the periodontal pocket	168 days (24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	168 days (24 weeks)
Probing Pocket Depth	Measuring the distance between the gingival sulcus and the bottom of the periodontal lesion	168 days (24 weeks)
Gingival Index	Visual Assessment of the inflammatory status of the gingiva according to the criteria set by Lobene et al.	168 days (24 weeks)
Plaque Index	Measuring the extent of supragingival plaque coverage according to the criteria set by Silness and Loe	168 days (24 weeks)

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 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): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: periodontitis; air polishing; scaling; attachment gain; periodontal lesion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; 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