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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03098498
- Acronym / sponsor ID
- ATTGAIN16 / WuerzburgUH
- Keywords
- periodontitis, scaling, attachment gain, air polishing, periodontal lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- controlled prospective parallel group intervention trial
| Arm | Type | Receives |
|---|---|---|
| Two-Stage Subgingival Debridement | Experimental | Procedure: Subgingival DebridementInitially 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 |
| One-Stage Subgingival Debridement | Active comparator | Procedure: Subgingival DebridementSoft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of periodontal disease
- minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
- minimum of 15 natural teeth
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subgingival DebridementAlso: Scaling and Root PlaningRemoval of subgingival bacterial biofilms and subgingival calculus from periodontal lesions | Procedure or surgery | One-Stage Subgingival Debridement, Two-Stage Subgingival Debridement |
Primary outcome
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
4 secondary outcomes
Change in Bleeding on Probing
Time frame: 168 days (24 weeks)
Change in Probing Pocket Depth
Time frame: 168 days (24 weeks)
Change in Gingival Index (GI)
Time frame: 168 days (24 weeks)
Change in Plaque Index
Time frame: 168 days (24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Schlagenhauf, Prof. Dr. principal investigator
Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subgingival Debridement in people with Periodontitis and Periodontal Attachment Loss, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Attachment Loss (time frame: 168 days (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.