Virgin Coconut Oil Versus Chlorhexidine Mouthwash in Non-Surgical Periodontal Therapy of Periodontitis Patients. A Randomized Controlled Clinical Trial With Biochemical Assessment.

July 11, 2026 updated by: Ain Shams University
This randomized controlled clinical trial will evaluate the effect of virgin coconut oil mouthwash compared with chlorhexidine mouthwash as an adjunct to non-surgical periodontal therapy in patients with stage II periodontitis. Participants will receive scaling and root planing, followed by the assigned mouthwash for 30 days. Clinical periodontal parameters, including plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level, will be recorded. Gingival crevicular fluid samples will also be collected to assess tumor necrosis factor-alpha levels before and after mouthwash use. The study aims to compare the clinical and biochemical effects of the two mouthwashes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • 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 Contact

Study Contact Backup

  • Name: Yasmine El-Sayed Fouad, Ass.Lecture
  • Phone Number: +201005793929

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11566
        • Faculty of Dentistry,Ain Shams University
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Both genders. 2. Age (30-50) years old. 3. Systemically free according to the modified Burkett's health history questionnaire .

    4. Generalized Periodontitis Stage II . 5. Having at least 20 tooth excluding wisdoms. 6. No history of dental visit in past three months. 7. Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.

Exclusion Criteria:

  • 1. Smokers. 2. Status of Pregnancy or Contraceptives usage. 3. Allergy to coconut oil . 4. Previous Periodontal treatment within the last 6 months. 5. Antibiotic and/or Anti-inflammatory therapy within the last 6 months.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chlorhexidine mouthwash group.
Patients with Stage II periodontitis will receive non-surgical periodontal therapy followed by chlorhexidine mouthwash according to the study protocol.
Procedure: Non-surgical periodontal therapy
Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.
Other: Chlorhexidine mouthwash
Chlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.
Experimental: Virgin coconut oil mouthwash group.
Patients with Stage II periodontitis will receive non-surgical periodontal therapy followed by virgin coconut oil mouthwash according to the study protocol.
Procedure: Non-surgical periodontal therapy
Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.
Other: Virgin coconut oil mouthwash
Virgin coconut oil mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level(CAL)
Time Frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use.
Clinical attachment level (CAL) will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a manual Michigan O periodontal probe with Williams markings. Measurements will be recorded at six sites per tooth for all teeth, excluding third molars. The mean CAL value will be calculated and recorded for each patient.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use.
Periodontal pocket depth(PPD)
Time Frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Periodontal pocket depth (PPD) will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a manual Michigan O periodontal probe with Williams markings. Measurements will be recorded at six sites per tooth for all teeth, excluding third molars. The mean PPD value will be calculated and recorded for each patient.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Plaque Index(PI)
Time Frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Plaque index (PI) will be assessed on the buccal and lingual surfaces of all teeth using a standardized 0-3 clinical scoring system. The mean PI score will be calculated and recorded for each patient. Surfaces with PI scores of 1, 2, or 3 will also be considered plaque-positive, and the percentage of plaque-positive surfaces will be calculated.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Gingival index(GI)
Time Frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Gingival index (GI) will be assessed on the buccal and lingual surfaces of all teeth using a standardized 0-3 clinical scoring system. The mean GI score will be calculated and recorded for each patient. Surfaces with GI scores of 1, 2, or 3 will also be considered inflammation-positive, and the percentage of inflammation-positive surfaces will be calculated.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Sulcus bleeding index (SBI)
Time Frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Sulcus bleeding index (SBI) will be assessed after gentle probing of the gingival sulcus using a standardized 0-3 clinical scoring system. The mean SBI score will be calculated and recorded for each patient. Sites with SBI scores of 1, 2, or 3 will also be considered bleeding-positive, and the percentage of bleeding-positive sites will be calculated.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gingival crevicular fluid TNF-alpha level
Time Frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Tumor necrosis factor-alpha (TNF-alpha) level will be measured in gingival crevicular fluid (GCF) samples collected using sterile perio paper strips. Samples will be analyzed using enzyme-linked immunosorbent assay (ELISA), and TNF-alpha concentration will be recorded for each patient.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Patient satisfaction regarding mouthwash-related side effects
Time Frame: At 4 weeks after mouthwash use.
Patient satisfaction regarding mouthwash-related side effects will be assessed using a patient questionnaire and clinical inspection after mouthwash use. The assessment will include taste alteration, tooth staining, supragingival calculus accumulation, and overall satisfaction with mouthwash use. Responses and clinical findings will be recorded and summarized for each patient
At 4 weeks after mouthwash use.

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Ahmed Amr, Professor, Faculty of dentistry-Ain Shams 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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-RecIM012386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. Only aggregated and de-identified results will be reported in the thesis and any related publications. Individual-level data will be kept confidential and accessible only to the study investigators, according to the informed consent and institutional ethics approval.

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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