Periodontal Attachment Loss, Periodontal; Lesion, Periodontitis
Conditions
Keywords
periodontitis, scaling, attachment gain, air polishing, periodontal lesion
Brief 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.
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.
Interventions
PROCEDURESubgingival Debridement
Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
controlled prospective parallel group intervention trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Bleeding on Probing | 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. |
| Change in Probing Pocket Depth | 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 |
| Change in Gingival Index (GI) | 168 days (24 weeks) | Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study |
| Change in Plaque Index | 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | One-Stage Subgingival Debridement | Total | Two-Stage Subgingival Debridement |
|---|---|---|---|
| Age, Continuous Age | 58.4 years STANDARD_DEVIATION 9.2 | 61.0 years STANDARD_DEVIATION 8.4 | 63.5 years STANDARD_DEVIATION 6.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 44 Participants | 22 Participants |
| Sex: Female, Male Female | 12 Participants | 26 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 18 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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
Time frame: 168 days (24 weeks)
Population: patients suffering from untreated severe chronic periodontitis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two-Stage Subgingival Debridement | Change in Clinical Attachment Loss | -1.08 mm | Standard Deviation 1.26 |
| One-Stage Subgingival Debridement | Change in Clinical Attachment Loss | -1.22 mm | Standard Deviation 0.9 |
Secondary
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.
Time frame: 168 days (24 weeks)
Population: patients suffering from untreated severe chronic periodontitis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two-Stage Subgingival Debridement | Change in Bleeding on Probing | -10 percentage of bleeding sites | Standard Deviation 40 |
| One-Stage Subgingival Debridement | Change in Bleeding on Probing | -20 percentage of bleeding sites | Standard Deviation 41 |
Secondary
Change in Gingival Index (GI)
Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study
Time frame: 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.
Secondary
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
Time frame: 168 days (24 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two-Stage Subgingival Debridement | Change in Plaque Index | -18 % of tooth surfaces | Standard Deviation 30 |
| One-Stage Subgingival Debridement | Change in Plaque Index | -8 % of tooth surfaces | Standard Deviation 34 |
Secondary
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
Time frame: 168 days (24 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two-Stage Subgingival Debridement | Change in Probing Pocket Depth | -1.53 mm | Standard Deviation 0.99 |
| One-Stage Subgingival Debridement | Change in Probing Pocket Depth | -1.17 mm | Standard Deviation 0.92 |