Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in Management of Periodontitis

July 6, 2026 updated by: Mansoura University

Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in the Management of Periodontitis

The aims of the current study are:

  1. Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients.
  2. Evaluation of the antioxidant effect of this treatment by the assessment of nuclear factor erythroid 2-related factor 2 (NrF2) and glutathione peroxidase 1 (GPX1) in the gingival crevicular fluid (GCF) samples.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Forty-five healthy patients with periodontitis and healthy subjects with healthy periodontium will be included in the current study. At the beginning of the treatment, all selected patients will be motivated about the benefit of plaque control and periodontal prophylaxis.

The participants will be selected from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment that they will receive and steps that will be taken. This includes the possible effects or risks and other treatment options according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. The subjects must understand this explanation in broad terms. They must be legally competent to give written consent before performing any required steps. The research protocol will be presented to the ethical committee at the Faculty of Dentistry, Mansoura University, to get its approval.

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.
45

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.
  • Not Applicable

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
      • Al Mansurah, Egypt
        • faculty of dentistry Mansoura university, Mansoura, 35516

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 25-55 years, either sex
  • Diagnosis of periodontal health OR Stage III periodontitis (per 2017 World Workshop Classification)

Exclusion Criteria:

  • Known allergy or sensitivity to any component of the study medication
  • Systemic antibiotics or anti-inflammatory medications within the preceding 6 months
  • Uncontrolled diabetes mellitus
  • Cardiovascular disease
  • Rheumatoid arthritis
  • Renal disease
  • Pulmonary disease
  • Thyroid disease
  • Malignancy
  • Current smokers
  • Pregnant or lactating women
  • Unable or unwilling to comply with prescribed oral hygiene instructions

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: None (Open Label)

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.
Experimental: group I treated with C. asiatica nanoemulsion as an adjunct to SRP
Group I (study group): 15 Patients with periodontitis Stage III will be treated with C. asiatica nanoemulsion as an adjunct to SRP.
Drug: Centella asiatica nanoemulsion gel
Following scaling and root planing, patients in Group 1 received local subgingival application of Centella asiatica nanoemulsion gel via disposable syringe with a blunt-ended cannula, applied once weekly for 3 months.
Procedure: Scaling and Root Planing (SRP)
Full-mouth scaling and root planing using ultrasonic instrumentation and Gracey curettes, plus standardized oral hygiene instructions.
Active Comparator: Group II (positive control group) treated with SRP
Group II (positive control): 15 patients with periodontitis Stage III will be treated with scaling and root planing (SRP) alone, with no adjunctive gel application.
Procedure: Scaling and Root Planing (SRP)
Full-mouth scaling and root planing using ultrasonic instrumentation and Gracey curettes, plus standardized oral hygiene instructions.
No Intervention: Group III (negative control group): no intervention
Group III (negative control/healthy control): 15 periodontally healthy participants who will receive no active periodontal intervention; assessed at baseline only

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
Plaque Index
Time Frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Full-mouth plaque accumulation scored at the mesial, distal, buccal, and lingual/palatal surfaces of each examined tooth on a 0-3 scale, with higher scores indicating greater plaque accumulation. The participant-level score is the average of all recorded surface scores.
Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival Index
Time Frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival inflammation was scored at each examined surface on a 0-3 scale based on gingival color, consistency, and presence/absence of bleeding on probing, with higher scores indicating more severe inflammation (0 = clinically healthy gingiva, 3 = severe inflammation with marked redness, edema, ulceration, or spontaneous bleeding).
Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival Bleeding Index
Time Frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Presence or absence of bleeding recorded following gentle probing of the gingival margin at each examined site, calculated as the number of bleeding sites divided by the total number of examined sites and expressed as a percentage. Higher percentages indicate greater gingival bleeding.
Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Periodontal Probing Depth (PPD)
Time Frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Distance in millimeters from the free gingival margin to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate deeper pockets and greater periodontal destruction.
Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Clinical Attachment Level (CAL)
Time Frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Distance in millimeters from the cemento-enamel junction to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate greater loss of periodontal attachment
Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)

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.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Majed M Alshammari, bachelor, Faculty of Dentistry Mansoura 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.
March 21, 2025

Primary Completion (Actual)

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.
September 8, 2025

Study Completion (Actual)

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.
September 8, 2025

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).
January 18, 2026

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.
July 6, 2026

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.
July 13, 2026

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.
July 13, 2026

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.
July 6, 2026

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.
July 1, 2026

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.
  • M0602025OM

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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