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Completed

NCT Number: NCT03098498

Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal; Lesion Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Periodontology, University Hospital Wuerzburg

Würzburg, 97070, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subgingival Debridement

Procedure

Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions

Other names: Scaling and Root Planing

Primary outcomes

  1. Change in Clinical Attachment Loss

    Time frame: 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 outcomes

  1. Change in Bleeding on Probing

    Time frame: 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.

  2. Change in Probing Pocket Depth

    Time frame: 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

  3. Change in Gingival Index (GI)

    Time frame: 168 days (24 weeks)

    Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study

  4. Change in Plaque Index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Acronym: ATTGAIN16

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2017
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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