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

August 10, 2021 updated by: Doaa Ahmed Yousef, Tanta University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
probing pocket depth
Time Frame: baseline
probing pocket depth will be recorded at baseline, at site that will be treated
baseline
probing pocket depth
Time Frame: 1 month
probing pocket depth will be recorded at 1 month at the site to be treated
1 month
probing pocket depth
Time Frame: 3 month
probing pocket depth will be recorded at 3 month at the site to be treated
3 month
clinical attachment level
Time Frame: baseline
clinical attachment level will be recorded at baseline,
baseline
clinical attachment level
Time Frame: 1 month
clinical attachment level will be recorded at , 1 month at the site to be treated
1 month
clinical attachment level
Time Frame: 3 month
clinical attachment level will be recorded at 3 months at the site to be treated
3 month
bleeding on probing
Time Frame: baseline
bleeding on probingwill be recorded at baseline, at the site to be treated
baseline
bleeding on probing
Time Frame: 1 month
bleeding on probingwill be recorded at 1, month at the site to be treated
1 month
bleeding on probing
Time Frame: 3 month
bleeding on probingwill be recorded at 3 months at the site to be treated
3 month
PCR for Porphyromonas gingivalis count
Time Frame: baseline
PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated
baseline
PCR for Porphyromonas gingivalis count
Time Frame: 1 month
PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated
1 month
PCR for Porphyromonas gingivalis count
Time Frame: 3 month
PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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