Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

Periodontitis Clinical Trial

— ATTGAIN16  

Official title:

Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03098498
• Other study ID #: WuerzburgUH
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2017
• Last updated: March 30, 2017
• Start date: June 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2017
• Source: Wuerzburg University Hospital
• Contact: Ulrich Schlagenhauf, Prof. Dr.
• Phone: 04993147083138
• Email: schlagenha_u[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Attachment Loss
• Periodontal; Lesion
• Periodontitis

Intervention

Procedure:
• Subgingival Debridement
Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions

Locations

Country	Name	City	State
Germany	Dept. of Periodontology, University Hospital Wuerzburg	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

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