Propolis-Based Solution Application in Extraction Socket Healing
24. juni 2026 opdateret af: Saint-Joseph University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Beirut, Libanon
- Saint Joseph University of Beirut
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Extraction site treated with a propolis-based solution
|
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." |
|
Aktiv komparator: Contralateral extraction site treated with saline mouthwash only
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Extraction Socket Surface Area Closure
Tidsramme: 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.
|
Baseline (Day 0), Day 7, and Day 14 post-extraction
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain Score
Tidsramme: 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.
|
Day 1, Day 3, and Day 7 post-extraction
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2025
Primær færdiggørelse (Faktiske)
1. april 2026
Studieafslutning (Faktiske)
1. april 2026
Datoer for studieregistrering
Først indsendt
18. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tfemd-2026-54
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .