Clinical trial NCT06624241: Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Periodontal Pocket
Periodontal Attachment Loss
Keywords: Curcumin
SRP
Liposome
Periodontitis
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\>7%, rheumatoid arthritis or any form of immunosuppression
* Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
* Chronic intake of NSAIDs or steroids, currently

Primary outcomes:
measure: Pocket Probing Depth (PPD)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Attachment Level (CAL)
timeFrame: 12 months
measure: Gingival Recession (GR)
timeFrame: 12 months
measure: Full Mouth Plaque Score
timeFrame: 12 months
measure: Full Mouth Bleeding Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. d&#39;Annunzio University
state: CH
Study officials:
affiliation: University 'G. D'Annunzio' of Chieti
name: Michele Paolantonio, DDS, MD
role: STUDY_CHAIR
References: