Efficacy of Curcumin Gel Combined With Non-surgical Periodontal Therapy on Salivary Procalcitonin Level in the Treatment of Periodontitis Patients

NCT05667376 | Completed

• 1 other identifier: A01031120
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To evaluate the efficacy of curcumin gel as an adjunct to scaling and root planing (SRP) on the salivary procalcitonin level in the treatment of periodontitis. Materials and methods: seventy patients (n=70) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, sixteen patients (n=16) were excluded as eight patients (n=8) weren't met the inclusion criteria, and other eight patients were divided into (n= 4) declined to participate with (n=4) were excluded due to pregnancy and lactation. The participants fifty -four patients were classified into three groups: group I (healthy individuals), group II (SRP group), and group III (curcumin gel group). Patients in groups II and III included stage II grade A periodontitis. Patients in group II were treated with SRP only while in group III curcumin gel was applied weekly for four weeks after SRP had been completed. Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)) and saliva samples for procalcitonin (PCT) assessment using an enzyme-linked immunosorbent assay (ELISA) test were collected and measured at baseline and again after six weeks.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth reduction

  Clinical attachment level gain

  Six weeks

Study Arms (1)

Study group

OTHER

Study group treated with curcumin gel

Other: Local drug delivery; Drug: curcumin gel

Interventions

Local drug delivery OTHER

Local application of curcumin gel into the periodontal pocket

Study group

curcumin gel DRUG

curcumin gel

Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Reham abdelfatah: lead

Study Sites (1)

Reham Ahmed Abdel-Fatah

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• Abdel-Fatah R, Mowafey B, Baiomy A, Elmeadawy S. Efficacy of curcumin gel as an adjunct to scaling and root planing on salivary procalcitonin level in the treatment of patients with chronic periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2023 Nov 19;23(1):883. doi: 10.1186/s12903-023-03512-y.

  PMID: 37981665 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Reham A Abdel-Fatah

  Mansoura university Faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The patients with periodontitis groups were randomly selected into either group II or III using the coin toss method. Hence the study groups were classified into three groups as follows, group I (negative control group): eighteen subjects with clinically healthy gingiva were selected to participate in the study as a reference group, and group II (positive control group): eighteen patients with periodontitis (stage II grade A) were selected and treated with non-surgical periodontal therapy (SRP) only, and group III (study group): eighteen patients with periodontitis (stage II grade A) were selected and treated with SRP followed by curcumin gel application
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BDS, Clinical demonstrator, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,

Model Details: patients (n=70) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, sixteen patients (n=16) were excluded as eight patients (n=6) weren't met the inclusion criteria and the other eight patients (n= 6) declined to participate with (n=4) were excluded due to pregnancy and lactation. The participants fifty -four patients were classified into three groups: group I (healthy individuals), group II (SRP group), and group III (curcumin gel group). Patients in group II and group III included patients with stage II grade A periodontitis. Patients in group II were treated with SRP only while in group III curcumin gel was applied weekly for four weeks after SRP had been completed.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

EG (1)