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Not yet recruiting NCT07706387

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

No phase Interventional Stage II Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-surgical periodontal therapy, Chlorhexidine mouthwash, Virgin coconut oil mouthwash.
Who it may be relevant to
Registry conditions: Stage II Periodontitis. Basic parameters: 30 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Clinical attachment level(CAL) [Time frame: 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]
  • Plaque Index(PI) [Time frame: 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]
  • Sulcus bleeding index (SBI) [Time frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use]
Secondary outcome measures (2)
  • 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]
  • Patient satisfaction regarding mouthwash-related side effects [Time frame: At 4 weeks after mouthwash use.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry,Ain Shams University — Cairo

Identifiers

NCT: NCT07706387 · FDASU-RecIM012386

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗