Trial Outcomes & Findings for Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy (NCT NCT03098498)
NCT ID: NCT03098498
Last Updated: 2024-10-31
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
168 days (24 weeks)
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
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
Subgingival Debridement: 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
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
Baseline characteristics by cohort
| Measure |
Two-Stage Subgingival Debridement
n=22 Participants
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
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
One-Stage Subgingival Debridement
n=22 Participants
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
63.5 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 168 days (24 weeks)Population: patients suffering from untreated severe chronic periodontitis
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
Outcome measures
| Measure |
Two-Stage Subgingival Debridement
n=22 Participants
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
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
One-Stage Subgingival Debridement
n=22 Participants
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
|---|---|---|
|
Change in Clinical Attachment Loss
|
-1.08 mm
Standard Deviation 1.26
|
-1.22 mm
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 168 days (24 weeks)Population: patients suffering from untreated severe chronic periodontitis
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.
Outcome measures
| Measure |
Two-Stage Subgingival Debridement
n=22 Participants
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
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
One-Stage Subgingival Debridement
n=22 Participants
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
|---|---|---|
|
Change in Bleeding on Probing
|
-10 percentage of bleeding sites
Standard Deviation 40
|
-20 percentage of bleeding sites
Standard Deviation 41
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Two-Stage Subgingival Debridement
n=22 Participants
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
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
One-Stage Subgingival Debridement
n=22 Participants
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
|---|---|---|
|
Change in Probing Pocket Depth
|
-1.53 mm
Standard Deviation 0.99
|
-1.17 mm
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 168 days (24 weeks)Population: In deviation from the original study protocol, the GI values were not recorded, as bleeding on probing is the relevant measure for assessing the extent of gingival inflammation according to the current classification adopted by the EFP/AAP.
Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Two-Stage Subgingival Debridement
n=22 Participants
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
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
One-Stage Subgingival Debridement
n=22 Participants
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
Subgingival Debridement: Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
|
|---|---|---|
|
Change in Plaque Index
|
-18 % of tooth surfaces
Standard Deviation 30
|
-8 % of tooth surfaces
Standard Deviation 34
|
Adverse Events
Two-Stage Subgingival Debridement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
One-Stage Subgingival Debridement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yvonne Jockel-Schneider
Department of Periodontology, University Hospital Wuerzburg
Phone: 49-931-201-72620
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place