Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

NCT ID: NCT03098498

Last Updated: 2024-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-09-01

Brief Summary

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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

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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.

Conditions

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Periodontitis Periodontal Attachment Loss Periodontal; Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

controlled prospective parallel group intervention trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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

Group Type EXPERIMENTAL

Subgingival Debridement

Intervention Type PROCEDURE

Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions

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

Group Type ACTIVE_COMPARATOR

Subgingival Debridement

Intervention Type PROCEDURE

Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions

Interventions

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Subgingival Debridement

Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions

Intervention Type PROCEDURE

Other Intervention Names

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Scaling and Root Planing

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Ulrich Schlagenhauf

Chairman Dept. of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrich Schlagenhauf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany

Locations

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Dept. of Periodontology, University Hospital Wuerzburg

Würzburg, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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WuerzburgUH

Identifier Type: -

Identifier Source: org_study_id

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