Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis

The Adjunctive Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis: Clinical and Microbiological Study.

This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: scaling and root planing; Procedure: Frankincense extract gel natural herbal product

Detailed Description

: twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31511
      • Doaa Ahmed yousef bayoumi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• systemically healthy patients were selected
• patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
• Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria:

• Smokers and pregnant patients.
• Medically compromised patients and systemic conditions precluding periodontal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; ten patients with sites suffering from mild chronic periodontitis sites will be treated with scaling and root planing (SRP) only	Procedure: scaling and root planing; will receive scaling and root planing only
Active Comparator: test group; Ten patients with sites suffering from mild chronic periodontitis. sites will be treated with scaling and root planing (SRP) and subgingival application of Frankincense extract gel	Procedure: scaling and root planing; will receive scaling and root planing only; Procedure: Frankincense extract gel natural herbal product; will receive Scaling and root planing then. Subgingival application of Frankincense extract gel; Other Names: Scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing pocket depth	probing pocket depth will be recorded at baseline, at site that will be treated	baseline
probing pocket depth	probing pocket depth will be recorded at 1 month at the site to be treated	1 month
probing pocket depth	probing pocket depth will be recorded at 3 month at the site to be treated	3 month
clinical attachment level	clinical attachment level will be recorded at baseline,	baseline
clinical attachment level	clinical attachment level will be recorded at , 1 month at the site to be treated	1 month
clinical attachment level	clinical attachment level will be recorded at 3 months at the site to be treated	3 month
bleeding on probing	bleeding on probingwill be recorded at baseline, at the site to be treated	baseline
bleeding on probing	bleeding on probingwill be recorded at 1, month at the site to be treated	1 month
bleeding on probing	bleeding on probingwill be recorded at 3 months at the site to be treated	3 month
PCR for Porphyromonas gingivalis count	PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated	baseline
PCR for Porphyromonas gingivalis count	PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated	1 month
PCR for Porphyromonas gingivalis count	PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated	3 month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Frankincense; non surgical treatment; chronic periodontitis.
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No