Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

NCT03098498 | Completed Results

• 1 other identifier: WuerzburgUH
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontal Attachment Loss; Periodontal; Lesion

Keywords

periodontitis; scaling; attachment gain; air polishing; periodontal lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Bleeding on Probing

  168 days (24 weeks)

• Change in Probing Pocket Depth

  168 days (24 weeks)

• Change in Gingival Index (GI)

  168 days (24 weeks)

• Change in Plaque Index

  168 days (24 weeks)

Study Arms (2)

Two-Stage Subgingival Debridement

EXPERIMENTAL

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

One-Stage Subgingival Debridement

ACTIVE COMPARATOR

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

Procedure: Subgingival Debridement

Interventions

Subgingival Debridement PROCEDURE

Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions

Also known as: Scaling and Root Planing

One-Stage Subgingival Debridement; Two-Stage Subgingival Debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of periodontal disease
• minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
• minimum of 15 natural teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Dept. of Periodontology, University Hospital Wuerzburg

Würzburg, 97070, Germany

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Attachment Loss

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Results Point of Contact

• Title: Dr. Yvonne Jockel-Schneider
• Organization: Department of Periodontology, University Hospital Wuerzburg

jockel_y@ukw.de

49-931-201-72620

Study Officials

• Ulrich Schlagenhauf, Prof. Dr.

  Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Dept. of Periodontology

Model Details: controlled prospective parallel group intervention trial

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 31, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)