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NCT Number: NCT07706387

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

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.

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Key information

Conditions

Stage II Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry,Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location contact

WASIM JOUMA ALHAYEK, B.D.S.

CONTACT

[email protected]

01023828515

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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.

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.

Treatment and study plan

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

Other

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

WASIM JOUMA ALHAYEK, B.D.S.

CONTACT

[email protected]

+201023828515

Yasmine El-Sayed Fouad, Ass.Lecture

CONTACT

+201005793929

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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