PeriodontitisATTGAIN16NCT03098498
Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
A study testing Subgingival Debridement in people with Periodontitis and Periodontal Attachment Loss, run by Wuerzburg University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Attachment Loss, Periodontal; Lesion
- What is being tested?
- Subgingival Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2016to 1 Sep 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of periodontal disease
- minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
- minimum of 15 natural teeth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Periodontology, University Hospital Wuerzburg
Würzburg, 97070
About this study
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.
Read the 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.
- Being tested
- Subgingival Debridement
- Keywords
- periodontitis, scaling, attachment gain, air polishing, periodontal lesion
- Medical subject headings
- Periodontitis, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival DebridementProcedure or surgery
Also called Scaling and Root Planing
Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Subgingival Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 168 days (24 weeks)
Secondary outcomes (4)
Change in Bleeding on Probing
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.
Measured: 168 days (24 weeks)
Change in Probing Pocket Depth
Difference in probing pocket depth between baseline and end of study in teeth with a baseline periodontal probing pocket depth ≥ 6 mm
Measured: 168 days (24 weeks)
Change in Gingival Index (GI)
Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study
Measured: 168 days (24 weeks)
Change in Plaque Index
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
Measured: 168 days (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Jun 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled prospective parallel group intervention trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital
- Investigators
- Ulrich Schlagenhauf, Prof. Dr., Principal investigator, Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098498
- Sponsor's protocol ID
- WuerzburgUH
- Acronym
- ATTGAIN16
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2017
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No