Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624241
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Effectiveness of SRP Lipo-curcumin Gel for the Treatment of Stage III Periodontitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Evaluation of Lipo-Curcumin Gel in Association with SRP for the Treatment of Stage III Periodontitis a Randomized and Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig SRP in association with lipo-curcumin gel LC respect SRP lipo-gel L SRP discharged D gel and SRP alone
This study will be designed as a randomized clinical trial of 12-month duration A total of 40 patients will be recruited and randomly equally distributed into 4 groups an experimental group treated with SRP LC a first control group treated with SRP L a second control group treated with SRPD and a third control group SRP alone
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia Caution will be taken to preserve the stability of soft tissues Following SRP experimental and control sites will be randomly chosen The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate in the third control group SRP alone will be performed
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe HuFriedy UNC 15 Before the treatment and at 6 and 12 months post-treatment all patients were examined by measuring the clinical attachment level probing depth gingival recession full-mouth plaque score and bleeding on probing
This study will be designed as a randomized clinical trial of 12-month duration A total of 40 patients will be recruited and randomly equally distributed into 4 groups an experimental group treated with SRP LC a first control group treated with SRP L a second control group treated with SRPD and a third control group SRP alone
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia Caution will be taken to preserve the stability of soft tissues Following SRP experimental and control sites will be randomly chosen The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate in the third control group SRP alone will be performed
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe HuFriedy UNC 15 Before the treatment and at 6 and 12 months post-treatment all patients were examined by measuring the clinical attachment level probing depth gingival recession full-mouth plaque score and bleeding on probing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None