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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05005767
• Other study ID #: 2D
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: March 2022

Study information

• Verified date: August 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• scaling and root planing
will receive scaling and root planing only
• Frankincense extract gel natural herbal product
will receive Scaling and root planing then. Subgingival application of Frankincense extract gel

Locations

Country	Name	City	State
Egypt	Doaa Ahmed yousef bayoumi	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

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