Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06131021
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-10-31
Brief Title:
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice A PBRN Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAAS
Brief Summary:
Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment However a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies suggesting that larger pragmatic clinical trials would benefit clinical decision making This will be a prospective randomized placebo-controlled trial stratified by practice and practitioner The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing SRP compared to SRP with placebo for the treatment of generalized stage II-III grades A-C periodontitis in approximately 544 patient participants from about 34 National Dental PBRN practices Periodontal data will be collected at baseline re-evaluation 6 weeks and final 12 months study visits Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin Metronidazole antibiotics AMXM versus SRP with Placebo
Detailed Description:
Précis Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment However a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies suggesting that larger pragmatic clinical trials would benefit clinical decision making This will be a prospective randomized placebo-controlled trial stratified by practice and practitioner The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing SRP compared to SRP with placebo for the treatment of generalized stage II-III grades A-C periodontitis in approximately 544 patient participants from about 34 National Dental PBRN practices Periodontal data will be collected at baseline re-evaluation 6 weeks and final 12 months study visits Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin Metronidazole antibiotics AMXM versus SRP with Placebo
Objectives and Outcomes Primary The primary objective will assess the effectiveness of SRP plus adjunctive antibiotics compared to SRP with placebo in periodontitis individuals from baseline to 6 weeks and 12 months following non-surgical periodontal therapy NSPT as determined by changes in site-level periodontal probing depth PD
Secondary To assess changes in i gingival inflammation measured by bleeding on probing BoP ii periodontal tissue attachment measured by clinical attachment level CAL iii reduction in diseased sites measured by remaining sites with maximum probing depth 5 mm and iv disease remission measured by number of participants with 4 sites with PD 5mm comparing SRP plus AMXM to SRP with a placebo adjunctive in periodontitis individuals from baseline to re-evaluation 6 weeks to final 12 month study visit following intervention The patient-reported impact of periodontal treatment measured by the Oral Health Impact Profile-5 OHIP-5 and treatment-related adverse events between groups will also be assessed
Population The sample size will be a target of approximately 544 patient participants enrolled from approximately 34 National Dental PBRN practices All patient participants are indicated to receive SRP and have been diagnosed with periodontitis stages II-III grades A-C
Description of Intervention The intervention will involve either SRP which is considered the standard of care treatment for debriding root surfaces in conjunction with 500 mg Amoxicillin and 500mg Metronidazole orally every 8 hours q8h for ten days following SRP or SRP with placebo
Objectives and Outcomes Primary The primary objective will assess the effectiveness of SRP plus adjunctive antibiotics compared to SRP with placebo in periodontitis individuals from baseline to 6 weeks and 12 months following non-surgical periodontal therapy NSPT as determined by changes in site-level periodontal probing depth PD
Secondary To assess changes in i gingival inflammation measured by bleeding on probing BoP ii periodontal tissue attachment measured by clinical attachment level CAL iii reduction in diseased sites measured by remaining sites with maximum probing depth 5 mm and iv disease remission measured by number of participants with 4 sites with PD 5mm comparing SRP plus AMXM to SRP with a placebo adjunctive in periodontitis individuals from baseline to re-evaluation 6 weeks to final 12 month study visit following intervention The patient-reported impact of periodontal treatment measured by the Oral Health Impact Profile-5 OHIP-5 and treatment-related adverse events between groups will also be assessed
Population The sample size will be a target of approximately 544 patient participants enrolled from approximately 34 National Dental PBRN practices All patient participants are indicated to receive SRP and have been diagnosed with periodontitis stages II-III grades A-C
Description of Intervention The intervention will involve either SRP which is considered the standard of care treatment for debriding root surfaces in conjunction with 500 mg Amoxicillin and 500mg Metronidazole orally every 8 hours q8h for ten days following SRP or SRP with placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4UH3DE031129-02 | NIH | None | httpsreporternihgovquickSearch4UH3DE031129-02 |