Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06624241

Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.

Led by G. d'Annunzio University · Updated on 2024-10-02

40

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a diagnosis of periodontitis stage III (grades A to C)
  • Non-smokers or former smokers who quit at least 1 year ago
  • No periodontal treatment in the 3 months prior to recruitment
  • Full-mouth plaque score (FMPS) less than 20% at baseline
  • No furcation involvement
  • Not pregnant or lactating
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of uncontrolled systemic diseases such as diabetes mellitus with HbA1C greater than 7%, rheumatoid arthritis, or any form of immunosuppression
  • Received systemic or local antibiotic therapy within 6 weeks before enrollment
  • Chronic intake of NSAIDs or steroids currently

AI-Screening

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Trial Site Locations

Total: 1 location

1

G. d'Annunzio University

Chieti, CH, Italy, 66100

Actively Recruiting

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Research Team

M

Michele Paolantonio, DDS, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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