Periodontitis
Conditions
Keywords
Stage II periodontitis, Stage III periodontitis, Scaling and root planing, Pomegranate peel extract, Local drug delivery, Split-mouth trial, Randomized clinical trial
Brief summary
This randomized, triple-blind, placebo-controlled split-mouth clinical trial aims to evaluate the clinical and biochemical efficacy of subgingival pomegranate peel extract gel as an adjunct to scaling and root planing (SRP) in the treatment of Stage II-III periodontitis. Thirty-two participants diagnosed with Stage II-III periodontitis will receive SRP in all selected periodontal sites. Test sites will receive locally delivered pomegranate peel extract gel, while contralateral control sites will receive a placebo gel. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP), and gingival crevicular fluid levels of matrix metalloproteinase-8 (MMP-8), will be assessed at baseline, 1 month, 3 months, and 6 months to evaluate whether adjunctive pomegranate peel extract gel improves periodontal healing compared with SRP alone.
Detailed description
Clinical outcomes including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) will be recorded at baseline, 1 month, 3 months, and 6 months. Gingival crevicular fluid samples will also be collected at the same time points for quantitative measurement of matrix metalloproteinase-8 (MMP-8) using enzyme-linked immunosorbent assay (ELISA).
Interventions
DRUGPomegranate Peel Extract Gel
Locally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing.
OTHERPlacebo gel
Placebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing.
Sponsors
gehad samy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, clinical operators administering the intervention, investigators responsible for clinical evaluation and data analysis, and outcome assessors are blinded to treatment allocation. Test and placebo gels are identical in appearance, consistency, and packaging. Randomization codes are maintained by an independent investigator until completion of data analysis.
Intervention model description
This is a randomized, placebo-controlled, triple-blind split-mouth clinical trial. Each participant receives both interventions: pomegranate peel extract gel is applied to randomly assigned periodontal sites, while contralateral sites receive placebo gel after scaling and root planing. Randomization is performed at the site level within each participant.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 30 to 60 years. * Systemically healthy individuals. * Diagnosis of Stage II or Stage III periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions. * Presence of at least 20 natural teeth. * Presence of at least two non-adjacent periodontal pockets (≥5 mm) located in different quadrants suitable for split-mouth allocation. * Clinical attachment loss consistent with Stage II or Stage III periodontitis. * Ability and willingness to comply with the study protocol and attend all follow-up visits. * Provision of written informed consent.
Exclusion criteria
* Current smokers or users of any tobacco products. * Pregnant or lactating women. * Patients with systemic diseases known to affect periodontal status or wound healing (e.g., uncontrolled diabetes mellitus, immunodeficiency disorders, osteoporosis requiring antiresorptive therapy). * Use of systemic antibiotics, corticosteroids, immunosuppressive agents, or non-steroidal anti-inflammatory drugs within the previous 3 months. * Periodontal therapy received within the previous 6 months. * History of allergy or hypersensitivity to pomegranate or any component of the study materials. * Orthodontic treatment during the study period. * Participation in another clinical trial within the previous 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline, 1 month, 3 months, and 6 months | Change in probing pocket depth (PPD), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Baseline, 1 month, 3 months, and 6 months | Change in clinical attachment level (CAL), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites. |
| Change in Plaque Index (PI) | Baseline, 1 month, 3 months, and 6 months | Change in plaque index (PI) assessed using the Silness and Löe Plaque Index. |
| Change in Gingival Index (GI) | Baseline, 1 month, 3 months, and 6 months | Change in gingival index (GI) assessed using the Löe and Silness Gingival Index. |
| Change in Bleeding on Probing (BOP) | Baseline, 1 month, 3 months, and 6 months | Change in bleeding on probing (BOP), assessed as the presence or absence of bleeding following gentle periodontal probing. |
| Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels | Baseline, 1 month, 3 months, and 6 months | Change in gingival crevicular fluid matrix metalloproteinase-8 (MMP-8) concentration measured using enzyme-linked immunosorbent assay (ELISA). |
Countries
Egypt
Contacts
CONTACTGehad Samy, BDS, MSc, PhD
Outcome results
None listed