Curcumin Paste as an Adjunctive Therapy in Periodontitis

NCT ID: NCT04032132

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-20
• Study Completion Date: 2018-11-05

Brief Summary

The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin when used in conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it may have positive effect)

Detailed Description

The present study entailed twenty four patients having stage II or stage III, Grade A periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was subjected to open flap debridement only. Group II was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin paste.The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

curcumin paste in conjunction with open flap debridement surge

curcumin paste (2% circumin) in conjunction with open flap debridement surgery

Group Type: EXPERIMENTAL

curcumin paste

Intervention Type: DRUG

curcumin is a herb used for medical purpose

curettage

Intervention Type: PROCEDURE

open flab debridement surgery

open flap debridement surgery only

surgical treatment for periodontal pocket

Group Type: PLACEBO_COMPARATOR

curettage

Intervention Type: PROCEDURE

open flab debridement surgery

Interventions

curcumin paste

curcumin is a herb used for medical purpose

Intervention Type: DRUG

curettage

open flab debridement surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Male or female with age range 25-45 years.

2. At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann & Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.

3. Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).

Exclusion Criteria

• 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Gamal

Administrator of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Y Gamal, professor

Role: STUDY_DIRECTOR

Faculty of dentistry -Ain Shams university

Other Identifiers

FER16 20-M

Identifier Type: -

Identifier Source: org_study_id