Stage II Periodontitis
Conditions
Keywords
Stage II periodontitis, virgin coconut oil mouthwash, TNF-alpha, Chlorhexidine mouthwash, Non-surgical periodontal therapy
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.
Interventions
PROCEDURENon-surgical periodontal therapy
Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.
OTHERChlorhexidine mouthwash
Chlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.
OTHERVirgin coconut oil mouthwash
Virgin coconut oil mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
TNF-alpha assessment will be performed by blinded laboratory personnel using coded GCF samples. Participants and investigators will not be masked.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level(CAL) | 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) | 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) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival crevicular fluid TNF-alpha level | 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. |
| Patient satisfaction regarding mouthwash-related side effects | 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 |
Countries
Egypt
Contacts
CONTACTWASIM JOUMA ALHAYEK, B.D.S.
CONTACTYasmine El-Sayed Fouad, Ass.Lecture
STUDY_DIRECTORAhmed Amr, Professor
Faculty of dentistry-Ain Shams University
Outcome results
None listed