Stage II PeriodontitisNCT07706387
Virgin Coconut Oil Versus Chlorhexidine Mouthwash in Non-Surgical Periodontal Therapy of Periodontitis Patients. A Randomized Controlled Clinical Trial With Biochemical Assessment.
A study testing Non-surgical periodontal therapy, Chlorhexidine mouthwash and Virgin coconut oil mouthwash in people with Stage II Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stage II Periodontitis
- What is being tested?
- Non-surgical periodontal therapy, Chlorhexidine mouthwash and Virgin coconut oil mouthwash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasmine El-Sayed Fouad, Ass.Lecture contact
Egypt1 site
Faculty of Dentistry,Ain Shams University
Cairo, Cairo Governorate, 11566
WASIM JOUMA ALHAYEK, B.D.S., 01023828515, doctor.wasem.94@gmail.com
About this study
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
- Being tested
- Non-surgical periodontal therapy, Chlorhexidine mouthwash, Virgin coconut oil mouthwash
- Keywords
- Stage II periodontitis, virgin coconut oil mouthwash, TNF-alpha, Chlorhexidine mouthwash, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.
Chlorhexidine mouthwashOther
Chlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.
Virgin coconut oil mouthwashOther
Virgin coconut oil mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non-surgical periodontal therapy; Other: Virgin coconut oil mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Patient satisfaction regarding mouthwash-related side effects
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
Measured: At 4 weeks after mouthwash use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Amr, Professor, Study director, Faculty of dentistry-Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706387
- Sponsor's protocol ID
- FDASU-RecIM012386
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virgin Coconut Oil Versus Chlorhexidine Mouthwash in Non-Surgical Periodontal Therapy of Periodontitis Patients. A Randomized Controlled Clinical Trial With Biochemical Assessment.
- ClinicalTrials.gov ID
- NCT07706387
- Acronym / sponsor ID
- FDASU-RecIM012386
- Conditions
- Stage II Periodontitis
- Keywords
- Stage II periodontitis, virgin coconut oil mouthwash, TNF-alpha, Chlorhexidine mouthwash, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine mouthwash group. | Active comparator | Procedure: Non-surgical periodontal therapy, Other: Chlorhexidine mouthwashPatients with Stage II periodontitis will receive non-surgical periodontal therapy followed by chlorhexidine mouthwash according to the study protocol. |
| Virgin coconut oil mouthwash group. | Experimental | Procedure: Non-surgical periodontal therapy, Other: Virgin coconut oil mouthwashPatients with Stage II periodontitis will receive non-surgical periodontal therapy followed by virgin coconut oil mouthwash according to the study protocol. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal therapyFull-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy. | Procedure or surgery | Chlorhexidine mouthwash group., Virgin coconut oil mouthwash group. |
| Chlorhexidine mouthwashChlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol. | Other | Chlorhexidine mouthwash group. |
| Virgin coconut oil mouthwashVirgin coconut oil mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol. | Other | Virgin coconut oil mouthwash group. |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasmine El-Sayed Fouad, Ass.Lecture contact
Ahmed Amr, Professor study director
Faculty of dentistry-Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal therapy, Chlorhexidine mouthwash and Virgin coconut oil mouthwash in people with Stage II Periodontitis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WASIM JOUMA ALHAYEK, B.D.S. (+201023828515, doctor.wasem.94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level(CAL) (time frame: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.