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

Primary Purpose

Chronic Periodontitis

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

scaling and root planing

Frankincense extract gel natural herbal product

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis., Frankincense, non surgical treatment

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Doaa Ahmed yousef bayoumi

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

test group

Arm Description

ten patients with sites suffering from mild chronic periodontitis sites will be treated with scaling and root planing (SRP) only

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

Outcomes

Primary Outcome Measures

probing pocket depth

probing pocket depth will be recorded at baseline, at site that will be treated

probing pocket depth

probing pocket depth will be recorded at 1 month at the site to be treated

probing pocket depth

probing pocket depth will be recorded at 3 month at the site to be treated

clinical attachment level

clinical attachment level will be recorded at baseline,

clinical attachment level

clinical attachment level will be recorded at , 1 month at the site to be treated

clinical attachment level

clinical attachment level will be recorded at 3 months at the site to be treated

bleeding on probing

bleeding on probingwill be recorded at baseline, at the site to be treated

bleeding on probing

bleeding on probingwill be recorded at 1, month at the site to be treated

bleeding on probing

bleeding on probingwill be recorded at 3 months at the site to be treated

PCR for Porphyromonas gingivalis count

PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated

PCR for Porphyromonas gingivalis count

PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated

PCR for Porphyromonas gingivalis count

PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated

Secondary Outcome Measures

Full Information

NCT ID

NCT05005767

First Posted

July 31, 2021

Last Updated

August 10, 2021

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05005767

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

chronic periodontitis., Frankincense, non surgical treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

twenty patients will be randomly be 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.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

ten patients with sites suffering from mild chronic periodontitis sites will be treated with scaling and root planing (SRP) only

Arm Title

test group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

scaling and root planing

Intervention Description

will receive scaling and root planing only

Intervention Type

Procedure

Intervention Name(s)

Frankincense extract gel natural herbal product

Other Intervention Name(s)

Scaling and root planing

Intervention Description

will receive Scaling and root planing then. Subgingival application of Frankincense extract gel

Primary Outcome Measure Information:

Title

probing pocket depth

Description

probing pocket depth will be recorded at baseline, at site that will be treated

Time Frame

baseline

Title

probing pocket depth

Description

probing pocket depth will be recorded at 1 month at the site to be treated

Time Frame

1 month

Title

probing pocket depth

Description

probing pocket depth will be recorded at 3 month at the site to be treated

Time Frame

3 month

Title

clinical attachment level

Description

clinical attachment level will be recorded at baseline,

Time Frame

baseline

Title

clinical attachment level

Description

clinical attachment level will be recorded at , 1 month at the site to be treated

Time Frame

1 month

Title

clinical attachment level

Description

clinical attachment level will be recorded at 3 months at the site to be treated

Time Frame

3 month

Title

bleeding on probing

Description

bleeding on probingwill be recorded at baseline, at the site to be treated

Time Frame

baseline

Title

bleeding on probing

Description

bleeding on probingwill be recorded at 1, month at the site to be treated

Time Frame

1 month

Title

bleeding on probing

Description

bleeding on probingwill be recorded at 3 months at the site to be treated

Time Frame

3 month

Title

PCR for Porphyromonas gingivalis count

Description

PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated

Time Frame

baseline

Title

PCR for Porphyromonas gingivalis count

Description

PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated

Time Frame

1 month

Title

PCR for Porphyromonas gingivalis count

Description

PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Doaa Ahmed yousef bayoumi

City

Tanta

State/Province

Gharbiya

ZIP/Postal Code

31511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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