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

NCT06624241 | Recruiting DMC

• 1 other identifier: 12062024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss

Keywords

Curcumin; SRP; Liposome; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Pocket Probing Depth (PPD)

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

  12 months

Secondary Outcomes (4)

• Clinical Attachment Level (CAL)

  12 months

• Gingival Recession (GR)

  12 months

• Full Mouth Plaque Score

  12 months

• Full Mouth Bleeding Score

  12 months

Study Arms (4)

Lipo-Curcumin gel + SRP

EXPERIMENTAL

After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate.

Procedure: Lipo-Curcumin gel + SRP

Lipo gel + SRP

ACTIVE COMPARATOR

After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate

Procedure: Lipo gel + SRP

Discharged Gel + SRP

ACTIVE COMPARATOR

After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate

Procedure: Discharged Gel + SRP

SRP alone

ACTIVE COMPARATOR

SRP alone will be performed.

Procedure: SRP alone

Interventions

Lipo-Curcumin gel + SRP 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-Curcumin gel + SRP

Lipo gel + SRP 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.

Lipo gel + SRP

Discharged Gel + SRP 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.

Discharged Gel + SRP

SRP alone 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.

SRP alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d&#39;Annunzio University

Chieti, CH, 66100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Michele Paolantonio, DDS, MD

  University 'G. D'Annunzio' of Chieti

  STUDY CHAIR

Central Study Contacts

Michele Paolantonio, DDS, MD

CONTACT

3395204073; michelepaolantonio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Periodontology

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: June 12, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)