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

ConditionsPeriodontal DiseasesPeriodontal PocketPeriodontal Attachment Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorG. d'Annunzio University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lipo-Curcumin gel + SRP

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Lipo-Curcumin gel + SRPExperimental treatment 1 intervention
Group B: Lipo gel + SRPActive comparator 1 intervention
Group C: Discharged Gel + SRPActive comparator 1 intervention
Group D: SRP aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pocket Probing Depth (PPD)

Distance between the gingival margin and the bottom of the pocket.

Time frame
12 months

Secondary outcomes

1

Clinical Attachment Level (CAL)

Distance between the CEJ and the bottom of the pocket

Time frame
12 months
2

Gingival Recession (GR)

Distance between the CEJ and the gingival margin.

Time frame
12 months
3

Full Mouth Plaque Score

Index that evaluates the general presence of bacterial plaque for all teeth. Through the passage of the probe, the presence of plaque deposits is reported for 4 surfaces for each tooth. A ratio is made between the contaminated surfaces and the total surfaces investigated to obtain a percentage value.

Time frame
12 months
4

Full Mouth Bleeding Score

Index that evaluates the general presence of bleeding for all teeth. Through the insertion of a periodontal probe, the presence of bleeding on probing is signaled for 4 sites for each tooth. A ratio is made between the bleeding sites and the total sites investigated to obtain a percentage value.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

G. d'Annunzio University

Lead sponsor

Source ClinicalTrials.gov
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