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

NCT07706387 | Not Yet Recruiting DMC

• 1 other identifier: FDASU-RecIM012386
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage II Periodontitis

Keywords

Stage II periodontitis; virgin coconut oil mouthwash; TNF-alpha; Chlorhexidine mouthwash; Non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (5)

• Clinical attachment level(CAL)

  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)

  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)

  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)

  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)

  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 Outcomes (2)

• Change in gingival crevicular fluid TNF-alpha level

  From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use

• Patient satisfaction regarding mouthwash-related side effects

  At 4 weeks after mouthwash use.

Study Arms (2)

Chlorhexidine mouthwash group.

ACTIVE COMPARATOR

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; Other: Chlorhexidine mouthwash

Virgin coconut oil mouthwash group.

EXPERIMENTAL

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; Other: Virgin coconut oil mouthwash

Interventions

Non-surgical periodontal therapy PROCEDURE

Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.

Chlorhexidine mouthwash group.; Virgin coconut oil mouthwash group.

Chlorhexidine mouthwash OTHER

Chlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.

Chlorhexidine mouthwash group.

Virgin coconut oil mouthwash OTHER

Virgin coconut oil mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.

Virgin coconut oil mouthwash group.

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry,Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Amr, Professor

  Faculty of dentistry-Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

WASIM JOUMA ALHAYEK, B.D.S.

CONTACT

+201023828515; doctor.wasem.94@gmail.com

Yasmine El-Sayed Fouad, Ass.Lecture

CONTACT

+201005793929

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: TNF-alpha assessment will be performed by blinded laboratory personnel using coded GCF samples. Participants and investigators will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)