PeriodontitisPOME-PERIONCT07725393
Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis
A study testing Pomegranate Peel Extract Gel in people with Periodontitis, run by gehad samy at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Pomegranate Peel Extract Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Jan 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Cairo Governorate
Gehad Samy, BDS, MSc, PhD, +201092710515, gehadasaad.26@azhar.edu.eg
Gehad Samy, BDS, MSc, PhD
About this study
Official title: Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis: A Randomized Split-Mouth Trial
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.
Read the 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).
- Conditions
- Periodontitis
- Being tested
- Pomegranate Peel Extract Gel, Placebo gel
- Keywords
- Stage II periodontitis, Stage III periodontitis, Scaling and root planing, Pomegranate peel extract, Local drug delivery, Split-mouth trial, Randomized clinical trial
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate Peel Extract GelDrug
Locally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing.
Placebo gelOther
Placebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate Peel Extract Gel | Experimental | Periodontal sites receive scaling and root planing followed by subgingival application of pomegranate peel extract gel. Receives: Drug: Pomegranate Peel Extract Gel |
| Placebo Gel | Placebo comparator | Periodontal sites receive scaling and root planing followed by subgingival application of placebo gel with identical appearance and consistency. Receives: Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Change in probing pocket depth (PPD), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (5)
Change in Clinical Attachment Level (CAL)
Change in clinical attachment level (CAL), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Plaque Index (PI)
Change in plaque index (PI) assessed using the Silness and Löe Plaque Index.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Gingival Index (GI)
Change in gingival index (GI) assessed using the Löe and Silness Gingival Index.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Bleeding on Probing (BOP)
Change in bleeding on probing (BOP), assessed as the presence or absence of bleeding following gentle periodontal probing.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels
Change in gingival crevicular fluid matrix metalloproteinase-8 (MMP-8) concentration measured using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- gehad samy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, gehad samy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725393
- Sponsor's protocol ID
- P-PD-26-09
- Acronym
- POME-PERIO
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luchian I, Goriuc A, Sandu D, Covasa M. The Role of Matrix Metalloproteinases (MMP-8, MMP-9, MMP-13) in Periodontal and Peri-Implant Pathological Processes. Int J Mol Sci. 2022 Feb 4;23(3):1806. doi: 10.3390/ijms23031806.
PubMed 35163727Tyagi P, Dodwad V, Kukreja BJ, Kukreja P. A comparison of the efficacy of scaling and root planning with application of pomegranate chip, pomegranate gel, and scaling and root planing in sufferers with adult periodontitis - A prospective study. J Indian Soc Periodontol. 2021 Jan-Feb;25(1):41-46. doi: 10.4103/jisp.jisp_243_20. Epub 2021 Jan 7.
PubMed 33642740
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis: A Randomized Split-Mouth Trial
- ClinicalTrials.gov ID
- NCT07725393
- Acronym / sponsor ID
- POME-PERIO / P-PD-26-09
- Conditions
- Periodontitis
- Keywords
- Stage II periodontitis, Stage III periodontitis, Scaling and root planing, Pomegranate peel extract, Local drug delivery, Split-mouth trial, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- gehad samyUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 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, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pomegranate Peel Extract Gel | Experimental | Drug: Pomegranate Peel Extract GelPeriodontal sites receive scaling and root planing followed by subgingival application of pomegranate peel extract gel. |
| Placebo Gel | Placebo comparator | Other: Placebo gelPeriodontal sites receive scaling and root planing followed by subgingival application of placebo gel with identical appearance and consistency. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Pomegranate Peel Extract GelLocally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing. | Drug | Pomegranate Peel Extract Gel |
| Placebo gelPlacebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing. | Other | Placebo Gel |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: 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.
5 secondary outcomes
Change in Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Plaque Index (PI)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Gingival Index (GI)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Bleeding on Probing (BOP)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels
Time frame: Baseline, 1 month, 3 months, and 6 months
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 24 Jul 2026.
- Background: PubMed 35163727Luchian I, Goriuc A, Sandu D, Covasa M. The Role of Matrix Metalloproteinases (MMP-8, MMP-9, MMP-13) in Periodontal and Peri-Implant Pathological Processes. Int J Mol Sci. 2022 Feb 4;23(3):1806. doi: 10.3390/ijms23031806.
- Background: PubMed 33642740Tyagi P, Dodwad V, Kukreja BJ, Kukreja P. A comparison of the efficacy of scaling and root planning with application of pomegranate chip, pomegranate gel, and scaling and root planing in sufferers with adult periodontitis - A prospective study. J Indian Soc Periodontol. 2021 Jan-Feb;25(1):41-46. doi: 10.4103/jisp.jisp_243_20. Epub 2021 Jan 7.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate Peel Extract Gel in people with Periodontitis, run by gehad samy 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 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. Some participants in this study may receive a placebo. 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 Gehad Samy, BDS, MSc, PhD (+201092710515, gehadasaad.26@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07725393, which also lists 2 linked publications.
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 24 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.