Clinical and Anti-inflammatory Effect of Curcumin Oral Gel as Adjuncts in Treatment of Periodontal Pocket

NCT04355416 | Unknown Early Phase 1

• 1 other identifier: college of dentistry
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

application of 1% curcumin gel in clinical study design will be used . The study will be conducted in Al-Najaf specialised dentistry center. The group of patients will be consist of 25 patients, belonging to both sex, age between 30-45 years. All patients will be diagnosed as chronic periodontitis with periodontal pockets of depth 5-7mm bilaterally to be randomly selected.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (6)

• measuring interleukin -8

  measuring interleukin -8 in gingival crevicular fluid by using ELISA

  one month

• measuring plaque accumulation

  measuring plaque accumulation on the teeth by measuring the plaque index using periodontal probe

  one month

• measuring gingival inflammation

  measuring gingival inflammation by measuring the gingival index by using periodontal probe

  one month

• measuring periodontal pocket erosion

  measuring periodontal pocket erosion and destruction by measuring bleeding on probing index using periodontal probe

  one month

• measuring the periodontal pocket depth

  measuring the periodontal pocket depth by using periodontal pocket depth index using periodontal probe

  one month

• measuring periodontal attachment level

  measuring periodontal attachment level by measuring clinical attachment level index using periodontal probe

  one month

Study Arms (2)

curcumin oral gel

EXPERIMENTAL

Drug: curcumin Oral gel; Procedure: subgingival scaling and root planing

subgingival scaling and root planing

OTHER

Procedure: subgingival scaling and root planing

Interventions

curcumin Oral gel DRUG

application of curcumin oral gel after scaling and root planing

curcumin oral gel

subgingival scaling and root planing PROCEDURE

subgingival scaling and root planing without application of curcumin gel

curcumin oral gel; subgingival scaling and root planing

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age group of 30-45 years.
• Belonging to both sexes.
• Chronic periodontitis patients.
• Probing pocket depth (PPD) 5-7 mm.

You may not qualify if:

• Subjects having taken antibiotics prior to or during the trial.
• Patients on medication likely to induce gingival enlargement.
• Pregnant or lactating women.
• Smokers.
• Tobacco chewers.
• Allergy to curcumin oral gel.
• Patients with systemic disease.

Sponsors & Collaborators

• University of Baghdad: lead
• Najaf dental specialized center: collaborator

Study Sites (1)

university of Baghdad college of dentistry

Baghdad, +964, Iraq

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Dental Scaling; Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry; Subgingival Curettage

Central Study Contacts

Haider Th Farhood, B.D.S

CONTACT

+9647811967728; haideralhisnawi19.12.88@gmail.com

Basima Gh Ali, MSc

CONTACT

+9647705027397; Dr.basimaali@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: care provider not involved in the study
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist dentist

Model Details: Twenty five systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket to determine the level of IL\_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: April 20, 2020
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

IR (1)