HealthyPhase 1/2NCT07665814
Propolis-Based Solution Application in Extraction Socket Healing
A Phase 1/2 study testing Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract) in people with Healthy, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propolis-Based Solution Application in Extraction Socket Healing: A 3D Split-Mouth Clinical Pilot Study
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.
- Conditions
- Healthy
- Being tested
- Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract), Saline rinse (control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Extraction site treated with a propolis-based solution | Experimental | Not described Receives: 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 | Not described Receives: Other: Saline rinse (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Extraction Socket Surface Area Closure
Percentage reduction in socket surface area from baseline, calculated from 3D intraoral scans using the formula: % Closure = (Baseline area - Timepoint area) / Baseline area × 100.
Measured: Baseline (Day 0), Day 7, and Day 14 post-extraction
Secondary outcomes (1)
Postoperative Pain Score
Pain intensity rated on a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater pain.
Measured: Day 1, Day 3, and Day 7 post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Split-mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665814
- Sponsor's protocol ID
- Tfemd-2026-54
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing beyond what is reported in this article is not currently planned. The informed consent obtained from participants covered publication of anonymized results and clinical images within the manuscript but did not include explicit provisions for sharing de-identified, individual-level data with third-party researchers. Additionally, given the small sample size (12-13 participants) drawn from a single institution, there is an elevated risk that combinations of variables in a shared dataset could allow indirect re-identification of participants.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis-Based Solution Application in Extraction Socket Healing: A 3D Split-Mouth Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT07665814
- Acronym / sponsor ID
- Tfemd-2026-54
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 24 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract)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." | Drug | Extraction site treated with a propolis-based solution |
| Saline rinse (control)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 | Other | Contralateral extraction site treated with saline mouthwash only |
Primary outcome
Percentage of Extraction Socket Surface Area Closure
Time frame: 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.
1 secondary outcome
Postoperative Pain Score
Time frame: Day 1, Day 3, and Day 7 post-extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing beyond what is reported in this article is not currently planned. The informed consent obtained from participants covered publication of anonymized results and clinical images within the manuscript but did not include explicit provisions for sharing de-identified, individual-level data with third-party researchers. Additionally, given the small sample size (12-13 participants) drawn from a single institution, there is an elevated risk that combinations of variables in a shared dataset could allow indirect re-identification of participants.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract) in people with Healthy, run by Saint-Joseph University at 1 site in Lebanon.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jun 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 Lebanon. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Extraction Socket Surface Area Closure (time frame: Baseline (Day 0), Day 7, and Day 14 post-extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.