Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.
NCT ID: NCT06624241
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-12
2025-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lipo-Curcumin gel + SRP
After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate.
Lipo-Curcumin gel + SRP
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo- Curcumin gel. The pocket will be sealed with cyanoacrylate.
Lipo gel + SRP
After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate
Lipo gel + SRP
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo gel. The pocket will be sealed with cyanoacrylate.
Discharged Gel + SRP
After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate
Discharged Gel + SRP
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of discharged gel. The pocket will be sealed with cyanoacrylate.
SRP alone
SRP alone will be performed.
SRP alone
The pocket defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed.
Interventions
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Lipo-Curcumin gel + SRP
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo- Curcumin gel. The pocket will be sealed with cyanoacrylate.
Lipo gel + SRP
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo gel. The pocket will be sealed with cyanoacrylate.
Discharged Gel + SRP
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of discharged gel. The pocket will be sealed with cyanoacrylate.
SRP alone
The pocket defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
* Chronic intake of NSAIDs or steroids, currently
18 Years
80 Years
ALL
Yes
Sponsors
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G. d'Annunzio University
OTHER
Responsible Party
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Michele Paolantonio
Head of Periodontology
Principal Investigators
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Michele Paolantonio, DDS, MD
Role: STUDY_CHAIR
University 'G. D'Annunzio' of Chieti
Locations
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G. d'Annunzio University
Chieti, CH, Italy
Countries
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Central Contacts
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Other Identifiers
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12062024
Identifier Type: -
Identifier Source: org_study_id
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