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The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment.
The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.
The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-mouth Disinfection IPT | Active Comparator | Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks). |
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| Conventional IPT | Experimental | Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. |
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| Full-mouth IPT | Experimental | Initial periodontal treatment was performed in 2 sessions within 24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Klorhex® Gel, rinse and spray | Drug | Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth | 6 months after initial periodontal treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg) | Baseline, 3 and 6 months after initial periodontal treatment | |
| Level of A. Actinomycetemcomitans | Baseline, 3 and 6 months after initial periodontal treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basak Dogan, Prof. Dr. | Marmara University, Faculty of Dentistry, Department of Periodontology | Study Director |
| Dilek Mamaklioglu, Dr. | Marmara University, Faculty of Dentistry, Department of Periodontology | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22220822 | Background | Aimetti M, Romano F, Guzzi N, Carnevale G. Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. J Clin Periodontol. 2012 Mar;39(3):284-94. doi: 10.1111/j.1600-051X.2011.01795.x. Epub 2012 Jan 4. | |
| 10397519 | Background | Mongardini C, van Steenberghe D, Dekeyser C, Quirynen M. One stage full- versus partial-mouth disinfection in the treatment of chronic adult or generalized early-onset periodontitis. I. Long-term clinical observations. J Periodontol. 1999 Jun;70(6):632-45. doi: 10.1902/jop.1999.70.6.632. |
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Total of 54 subjects were assessed for eligibility. Prior to assignment of participants, 2 subjects declined to participate and 10 participants were not meeting inclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Full-mouth Disinfection IPT | Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks). |
| FG001 | Conventional IPT | Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. |
| FG002 | Full-mouth IPT | Initial periodontal treatment was performed in 2 sessions within 24 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Full-mouth Disinfection IPT | Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks). |
| BG001 | Conventional IPT |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Probing Depth | Posted | Mean | Standard Deviation | mm | 6 months after initial periodontal treatment |
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6 months
Only Other (Not Including Serious) Adverse Events were monitored, Serious Adverse Events were not monitored.
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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 | Full-mouth Disinfection IPT | Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Basak Dogan | Marmara University Faculty of Dentistry, Department of Periodontology | 00905332621170 | basak.sdogan@gmail.com |
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| ID | Term |
|---|---|
| D010520 | Aggressive Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Conventional IPT | Procedure | Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. |
|
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| Full-mouth IPT | Procedure | Initial periodontal treatment was performed in 2 sessions within 24 hours. |
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| Level of Porphyromonas Gingivalis | Baseline, 3 and 6 months after initial periodontal treatment |
| Level of Fusobacterium Nucleatum | Baseline, 3 and 6 months after initial periodontal treatment |
| Level of Parvimonas Micra | Baseline, 3 and 6 months after initial periodontal treatment |
| Bleeding on Probing | Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome. | Baseline, 3 and 6 months after initial periodontal treatment |
| Plaque Index | Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome | Baseline, 3 and 6 months after initial periodontal treatment |
| Gingival Index | Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome | Baseline, 3 and 6 months after initial periodontal treatment |
| Clinical Attachment Level | Baseline, 3 and 6 months after initial periodontal treatment |
| Level of Prevotella Intermedia | Baseline, 3 and 6 months after initial periodontal treatment |
| Level of Campylobacter Rectus | Baseline, 3 and 6 months after initial periodontal treatment |
| 22126282 | Background | de Lima Oliveira AP, de Faveri M, Gursky LC, Mestnik MJ, Feres M, Haffajee AD, Socransky SS, Teles RP. Effects of periodontal therapy on GCF cytokines in generalized aggressive periodontitis subjects. J Clin Periodontol. 2012 Mar;39(3):295-302. doi: 10.1111/j.1600-051X.2011.01817.x. Epub 2011 Nov 30. |
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. |
| BG002 | Full-mouth IPT | Initial periodontal treatment was performed in 2 sessions within 24 hours. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Initial periodontal treatment was performed in 2 sessions within 24 hours.
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| Secondary | Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg) | Posted | Mean | Standard Deviation | Picogram | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Level of A. Actinomycetemcomitans | Posted | Mean | Standard Deviation | log10(cells/ml) | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Level of Porphyromonas Gingivalis | Posted | Mean | Standard Deviation | log10(cells/ml) | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Level of Fusobacterium Nucleatum | Posted | Mean | Standard Deviation | log10(cells/ml) | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Level of Parvimonas Micra | Posted | Mean | Standard Deviation | log10(cells/ml) | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Bleeding on Probing | Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome. | Posted | Mean | Standard Deviation | percentage of BOP positive sites | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Plaque Index | Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Gingival Index | Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Clinical Attachment Level | Posted | Mean | Standard Deviation | mm | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Level of Prevotella Intermedia | Posted | Mean | Standard Deviation | log10(cells/ml) | Baseline, 3 and 6 months after initial periodontal treatment |
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| Secondary | Level of Campylobacter Rectus | Posted | Mean | Standard Deviation | log10(cells/ml) | Baseline, 3 and 6 months after initial periodontal treatment |
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| 0 |
| 0 |
| 0 |
| 14 |
| EG001 | Conventional IPT | Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. | 0 | 0 | 0 | 14 |
| EG002 | Full-mouth IPT | Initial periodontal treatment was performed in 2 sessions within 24 hours. | 0 | 0 | 0 | 14 |
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| 6th month IL-1β |
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| Baseline Interleukin-17 |
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| 3rd month IL-17 |
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| 6th month IL-17 |
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| 6th month A. actinomycetemcomitans level |
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| 6th month P. gingivalis level |
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| 6th month F. nucleatum level |
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| 6th month P. micra level |
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| 6th month BOP |
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| 6th month PI |
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| 6th month GI |
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| 6th month CAL |
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| 6th month P. intermedia level |
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| 6th month C. rectus level |
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