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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 SRP+D 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Patients with a diagnosis of periodontitis stage III (grades A to C)

• on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment

• FMPS \< 20% at baseline

• Furcation not involved

• Not Pregnant or Lactating

• Signed informed consent

Locations
Other Locations
Italy
G. d&#39;Annunzio University
RECRUITING
Chieti
Contact Information
Primary
Michele Paolantonio, DDS, MD
michelepaolantonio@gmail.com
3395204073
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2025-09
Participants
Target number of participants: 40
Treatments
Experimental: Lipo-Curcumin gel + SRP
After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate.
Active_comparator: Lipo gel + SRP
After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate
Active_comparator: Discharged Gel + SRP
After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate
Active_comparator: SRP alone
SRP alone will be performed.
Related Therapeutic Areas
Sponsors
Leads: G. d'Annunzio University

This content was sourced from clinicaltrials.gov