ClinicalTrials.gg
RecruitingNCT07725393POME-PERIOUpdated Jul 24, 2026

Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis

An interventional study of Pomegranate Peel Extract Gel and Placebo gel in Periodontitis, sponsored by gehad samy. Recruiting at 1 site in Egypt. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by gehad samy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 119 studies in Periodontitis with a site in Egypt — 28 open to participants now, 37 under way, 3 of them phase 3. Periodontitis · Egypt.

Planned enrollment
47th of 101
32 · median 30
Started
2026
with 10 others
No phase
61 of 119
18 open now
Primary completion
2027-01
later than 31 of 36 live
Registered
109th of 119
by date

Among the 119 studies in Periodontitis with a site in Egypt, this one is the 47th largest by planned enrollment of the 101 interventional ones that give a count, is one of 11 that started in 2026, is one of 61 with no phase, reaches primary completion later than 31 of the 36 other live ones, and was the 109th registered.

Periodontitis

1,232 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

Browse Periodontitis studies →

Open to participants now

28 of the 119 studies in Periodontitis with a site in Egypt are open now. Recruiting first, the newest first:

22 more — sign in →

All 28 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 158 Periodontitis studies recruiting now, 78 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 76 take healthy volunteers.

This study: 30 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

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).

03

Conditions studied

  • Periodontitis

Browse trials for

Keywords

  • Stage II periodontitis
  • Stage III periodontitis
  • Scaling and root planing
  • Pomegranate peel extract
  • Local drug delivery
  • Split-mouth trial
  • Randomized clinical trial
04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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, , agents, or non-steroidal anti-inflammatory drugs within the previous 3 months.
  • Periodontal therapy received within the previous 6 months.
  • History of allergy or 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Pomegranate Peel Extract Gel

    Periodontal sites receive scaling and root planing followed by subgingival application of pomegranate peel extract gel.

    Drug: Pomegranate Peel Extract Gel

  • Placebo comparator
    Placebo Gel

    Periodontal sites receive scaling and root planing followed by subgingival application of placebo gel with identical appearance and consistency.

    Other: Placebo gel

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 month, 3 months, and 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 1 month, 3 months, and 6 months

  2. Change in Plaque Index (PI)

    Change in plaque index (PI) assessed using the Silness and Löe Plaque Index.

    Time frame: Baseline, 1 month, 3 months, and 6 months

  3. Change in Gingival Index (GI)

    Change in gingival index (GI) assessed using the Löe and Silness Gingival Index.

    Time frame: Baseline, 1 month, 3 months, and 6 months

  4. Change in Bleeding on Probing (BOP)

    Change in bleeding on probing (BOP), assessed as the presence or absence of bleeding following gentle periodontal probing.

    Time frame: Baseline, 1 month, 3 months, and 6 months

  5. 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).

    Time frame: Baseline, 1 month, 3 months, and 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 35163727 ↗
  • Tyagi 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.

Of 481 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 6 months is below that.

Counting every sponsor, half of 495 studies reached it within 15 months; a quarter within 8 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Jul 24, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07725393
Lead sponsor
gehad samy
Responsible party
gehad samy (Lecturer of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dental Medicine for Girls, Al-Azhar University, Al-Azhar University) — Sponsor-investigator
First posted
Jul 24, 2026
Start date
Jul 1, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

Gehad Samy, BDS, MSc, PhD
Contact
gehadasaad.26@azhar.edu.eg
+201092710515

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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