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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal therapy | Procedure | Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WASIM JOUMA ALHAYEK, B.D.S. | Contact | +201023828515 | doctor.wasem.94@gmail.com | |
| Yasmine El-Sayed Fouad, Ass.Lecture | Contact | +201005793929 |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Amr, Professor | Faculty of dentistry-Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry,Ain Shams University | Cairo | Cairo Governorate | 11566 | Egypt |
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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TNF-alpha assessment will be performed by blinded laboratory personnel using coded GCF samples. Participants and investigators will not be masked.
| Chlorhexidine mouthwash | Other | Chlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol. |
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| 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. |
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| 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 |
| 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 | At 4 weeks after mouthwash use. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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