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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subgingival Debridement | Procedure | Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 168 days (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 168 days (24 weeks) |
| Change in Probing Pocket Depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Schlagenhauf, Prof. Dr. | Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Periodontology, University Hospital Wuerzburg | Würzburg | 97070 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | patients suffering from untreated severe chronic periodontitis | Posted | Mean | Standard Deviation | mm | 168 days (24 weeks) |
|
Occurring adverse event data were collected from baseline to the end of study (168 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yvonne Jockel-Schneider | Department of Periodontology, University Hospital Wuerzburg | 49-931-201-72620 | jockel_y@ukw.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2016 | Nov 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D017622 | Periodontal Attachment Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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controlled prospective parallel group intervention trial
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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.
|
Difference in probing pocket depth between baseline and end of study in teeth with a baseline periodontal probing pocket depth ≥ 6 mm |
| 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 | 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 | 168 days (24 weeks) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
| 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. | patients suffering from untreated severe chronic periodontitis | Posted | Mean | Standard Deviation | percentage of bleeding sites | 168 days (24 weeks) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm | 168 days (24 weeks) |
|
|
|
| Secondary | Change in Gingival Index (GI) | Measuring the mean difference in Gingival Index (GI) scores between baseline and end of the study | 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. | Posted | 168 days (24 weeks) |
|
|
| 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 | Posted | Mean | Standard Deviation | % of tooth surfaces | 168 days (24 weeks) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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 | 0 | 22 | 0 | 22 | 0 | 22 |
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| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |