Propolis-Based Solution Application in Extraction Socket Healing

NCT07665814 — Phase 1 / Phase 2, Completed, 14 participants, Saint-Joseph University

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Propolis-Based Solution Application in Extraction Socket Healing: A 3D Split-Mouth Clinical Pilot Study

Registry	NCT07665814
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; non randomized, crossover, masking: single, treatment
Enrollment	14 (Actual)
Sponsor	Saint-Joseph University (Other)
Conditions	Healthy
Interventions	Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract), Saline rinse (control) (Drug, other)
Dates	start 2025-10-01, primary completion 2026-04-01, completion 2026-04-01, first posted 2026-06-24, last updated 2026-06-29
Locations	1 site in Lebanon

-Summary

This pilot study evaluated whether a propolis-based topical solution improves soft-tissue healing after tooth extraction. Thirteen patients requiring extraction of two comparable teeth on opposite sides of the mouth were enrolled in a split-mouth design, in which one extraction site received the propolis solution while the other served as an internal control. The test site was treated with the propolis solution three times daily for seven days, while the control site received only saline rinses. Healing was tracked using 3D intraoral scans obtained before extraction and on days 7 and 14 afterward, allowing the percentage of socket closure to be measured objectively over time. Postoperative pain was also assessed using a standard visual pain scale on days 1, 3, and 7. The study aimed to determine whether this propolis-based formulation could serve as a natural, low-cost adjunct to standard post-extraction care to support faster tissue repair.

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+Arms and interventions

Arm	Type	Interventions	Description
Extraction site treated with a propolis-based solution	Experimental	Drug: Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract)
Contralateral extraction site treated with saline mouthwash only	Active comparator	Other: Saline rinse (control)

Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract) (Drug): Drug: Propolis-Based Solution "A topical solution (52% propolis extract, clove oil, and white willow bark extract) applied to the test extraction socket via brush applicator three times daily for seven days."
Saline rinse (control) (Other): The contralateral extraction socket received saline mouthwash only, with no active therapeutic agent applied, following the same pre-application oral hygiene steps (tooth brushing and saline rinse) as the test site

+Outcome measures

Primary outcomes

Percentage of Extraction Socket Surface Area Closure [Baseline (Day 0), Day 7, and Day 14 post-extraction]: Percentage reduction in socket surface area from baseline, calculated from 3D intraoral scans using the formula: % Closure = (Baseline area - Timepoint area) / Baseline area × 100.

Secondary outcomes

Postoperative Pain Score [Day 1, Day 3, and Day 7 post-extraction]: Pain intensity rated on a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater pain.

+Eligibility

Sex: All, ages: 8 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Cooperative adult patients willing to accept the study protocol
* Minors with a cooperative parent/legal guardian providing consent
* Non-surgical extraction of bilaterally positioned teeth
* Low-to-moderate extraction difficulty per the Pederson scale
* Systemically healthy, with no history of systemic disease

Exclusion Criteria:

* Non-consenting patients
* Failure to attend follow-up appointments per protocol
* Heavy smokers (>10 pack-years)
* Systemic disease (e.g., diabetes mellitus, immunosuppressive syndromes)
* Current use of contraceptive medication
* Systemic antibiotic therapy within the previous 3 months
* Anticoagulant therapy within the previous 4 weeks
* Requirement for antibiotic prophylaxis
* Pregnant or breastfeeding women
* Known allergy to honey or bee-related products
* Known allergy to local anesthetics used in dental procedures
* Higher-difficulty extractions requiring sutures or other hemostatic measures

+Locations (1)

Facility	City	Country	Status
Saint Joseph University of Beirut	Beirut	Lebanon