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

NCT ID: NCT06624241

Last Updated: 2024-10-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Diseases Periodontal Pocket Periodontal Attachment Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type EXPERIMENTAL

Lipo-Curcumin gel + SRP

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Lipo gel + SRP

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Discharged Gel + SRP

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

SRP alone

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Michele Paolantonio

Head of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

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&#39;Annunzio University

Chieti, CH, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Michele Paolantonio, DDS, MD

Role: CONTACT

3395204073

Other Identifiers

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12062024

Identifier Type: -

Identifier Source: org_study_id

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