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Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction

NCT07874789 — Not applicable, Recruiting, 54 participants, Istanbul University

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Evaluation of the Effect of Curcumin Topical Spray on Post-Extraction Wound Healing and Postoperative Symptoms

RegistryNCT07874789
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment54 (Estimated)
SponsorIstanbul University (Other)
ConditionsWound Healing, Alveolitis of Jaw, Tooth Extraction, Curcumin
InterventionsCurcumin Topical Spray, Chlorhexidine Topical Spray (Dietary supplement, drug)
Datesstart 2026-09-29 (estimated), primary completion 2026-11-30 (estimated), completion 2027-01-25 (estimated), first posted 2026-10-15, last updated 2026-10-15
Locations1 site in Turkey (Türkiye)

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-Summary

This randomized, single-blind, controlled clinical trial aims to evaluate the effects of a topical curcumin spray on post-extraction wound healing and postoperative symptoms in adults undergoing first molar extraction. Participants will be randomly assigned to one of three groups: curcumin topical spray, 0.12% chlorhexidine topical spray, or standard postoperative care without a topical spray. The interventions will be applied twice daily for 7 days. Postoperative pain will be assessed using a visual analog scale, while wound healing will be evaluated using the Landry, Turnbull, and Howley Healing Index. Wound dimensions will also be recorded during follow-up. In addition, salivary levels of inflammatory biomarkers, including interleukin-1β (IL-1β), tumor necrosis factor-alpha (TNF-α), and prostaglandin E2 (PGE2), will be analyzed to assess the local inflammatory response during the postoperative healing period.The study aims to compare the clinical effects of topical curcumin with chlorhexidine and standard postoperative care during the early healing period after tooth extraction.

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+Detailed description

This study is designed as a randomized, single-blind, three-arm controlled clinical trial to evaluate the effect of a curcumin-containing topical spray on early wound healing and postoperative symptoms following first molar extraction in adults aged 18-40 years.

Eligible participants requiring first molar extraction will undergo minimally traumatic tooth extraction without primary suturing. Following extraction, participants will be randomly allocated to one of three study groups. Participants in the curcumin group will use a Curcuma longa-containing topical spray, administered as two sprays to the extraction site twice daily for 7 days. Participants in the chlorhexidine group will use a 0.12% chlorhexidine topical spray according to the same administration schedule. Participants in the control group will receive standard postoperative care without the use of an additional topical spray.

All participants will receive standardized postoperative instructions. Clinical follow-up will be performed during the early postoperative healing period. Postoperative pain will be assessed using a 0-10 visual analog scale (VAS) on postoperative days 1, 3, 5, and 7. Soft-tissue wound healing will be evaluated using the Landry, Turnbull, and Howley Healing Index on postoperative days 7 and 14. Wound dimensions will be measured in the buccolingual and mesiodistal directions during follow-up.

In addition to clinical assessments, salivary inflammatory biomarkers, including interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and prostaglandin E2 (PGE2), will be analyzed to evaluate the local inflammatory response associated with postoperative healing.

The study will compare clinical healing, postoperative pain, wound dimensions, mouth opening, and inflammatory biomarker levels among the curcumin, chlorhexidine, and control groups. The aim is to determine whether topical curcumin influences early post-extraction wound healing and postoperative inflammatory symptoms compared with chlorhexidine and standard postoperative care.

+Arms and interventions

ArmTypeInterventionsDescription
Curcumin Topical SprayExperimentalDietary Supplement: Curcumin Topical SprayParticipants will receive a Curcuma longa-containing topical spray applied to the extraction site as two sprays twice daily for 7 days, in addition to standard postoperative care.
Chlorhexidine Topical SprayActive comparatorDrug: Chlorhexidine Topical SprayParticipants will receive a 0.12% chlorhexidine topical spray applied to the extraction site as two sprays twice daily for 7 days, in addition to standard postoperative care.
Standard Postoperative CareNo interventionParticipants will receive standard postoperative care following tooth extraction without the use of an additional topical spray.
  • Curcumin Topical Spray (Dietary supplement): A commercially available Curcuma longa-containing topical spray (Minerelax®) will be applied directly to the extraction site as two sprays twice daily for 7 days following tooth extraction, in addition to standardized postoperative care.
  • Chlorhexidine Topical Spray (Drug), also known as Chlorhexidine 0.12% Topical Spray: 0.12% chlorhexidine topical spray administered to the extraction site as two sprays twice daily for 7 days.

+Outcome measures

Primary outcomes

  • Extraction Socket Healing Assessed Using the Landry, Turnbull and Howley Healing Index [postoperative 7. and 14. days]: Extraction socket healing will be assessed using the Landry, Turnbull and Howley Healing Index, ranging from 1 (very poor healing) to 5 (excellent healing). Higher scores indicate better wound healing. Scores will be compared among the curcumin spray, chlorhexidine spray, and standard postoperative care groups.

Secondary outcomes

  • Postoperative Pain Intensity [Postoperative days 1, 3, 5, and 7.]: Pain intensity at the extraction site will be assessed using a visual analog scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Assessments will be performed by telephone on days 1, 3, and 5 and at the clinical visit on day 7. Scores will be compared among the three study groups.
  • Change in Extraction Socket Wound Size [Day 0 following extraction and postoperative days 7 and 14.]: Wound size will be assessed by directly measuring the distance between predefined anatomical landmarks at the extraction site. Measurements on postoperative days 7 and 14 will be compared with the initial measurement obtained on day 0 and among the three study groups. A reduction in the measured distance indicates wound closure.
  • Change in Salivary Interleukin-1 Beta Concentration [Before extraction (day 0) and postoperative days 2 and 7.]: Salivary interleukin-1 beta (IL-1 beta) concentrations will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). Concentrations on postoperative days 2 and 7 and changes from the pre-extraction baseline will be compared among the three study groups to assess the local inflammatory response.
  • Change in Salivary Tumor Necrosis Factor Alpha Concentration [Before extraction (day 0) and postoperative days 2 and 7.]: Salivary tumor necrosis factor alpha (TNF-alpha) concentrations will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). Concentrations on postoperative days 2 and 7 and changes from the pre-extraction baseline will be compared among the three study groups to assess the local inflammatory response.
  • Change in Salivary Prostaglandin E2 Concentration [Before extraction (day 0) and postoperative days 2 and 7.]: Salivary prostaglandin E2 (PGE2) concentrations will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). Concentrations on postoperative days 2 and 7 and changes from the pre-extraction baseline will be compared among the three study groups to assess the local inflammatory response.

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy individuals aged 18-40 years with ASA physical status I.
* Patients scheduled for extraction of a mandibular first molar.
* Individuals who voluntarily agree to participate and provide written informed consent.
* Individuals without chronic systemic disease and who do not use regular medication.
* Patients with no oral health condition that would contraindicate the surgical procedure.

Exclusion Criteria:

* Pregnant or breastfeeding individuals.
* Patients with systemic diseases or immunosuppression.
* Individuals with a history of previous surgery or trauma in the same region.
* Individuals with a known allergy or hypersensitivity to turmeric (curcumin), chlorhexidine spray, or any component of the study products.
* Individuals who smoke or consume alcohol.
* Individuals who regularly use medications, particularly anti-inflammatory or anticoagulant drugs.

+Locations (1)

FacilityCityCountryStatus
Istanbul University Faculty of Dentistry, Department of Oral and Maxillofacial SurgeryIstanbul, IstanbulTurkey (Türkiye)Recruiting

+Publications

  • Results publication: Dei Cas M, Ghidoni R. Dietary Curcumin: Correlation between Bioavailability and Health Potential. Nutrients. 2019 Sep 8;11(9):2147. doi: 10.3390/nu11092147. PMID 31500361
  • Results publication: Amaliya A, Ramadhanti R, Hadikrishna I, Maulina T. The Effectiveness of 0.2% Chlorhexidine Gel on Early Wound Healing after Tooth Extraction: A Randomized Controlled Trial. Eur J Dent. 2022 Jul;16(3):688-694. doi: 10.1055/s-0041-1739544. Epub 2022 Jan 11. PMID 35016228
  • Results publication: Broers DLM, Dubois L, de Lange J, Su N, de Jongh A. Reasons for Tooth Removal in Adults: A Systematic Review. Int Dent J. 2022 Feb;72(1):52-57. doi: 10.1016/j.identj.2021.01.011. Epub 2021 Feb 26. PMID 33648772
  • Results publication: Sahebkar A, Henrotin Y. Analgesic Efficacy and Safety of Curcuminoids in Clinical Practice: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Med. 2016 Jun;17(6):1192-202. doi: 10.1093/pm/pnv024. Epub 2015 Dec 14. PMID 26814259
  • Results publication: Seyedzadeh MH, Safari Z, Zare A, Gholizadeh Navashenaq J, Razavi SA, Kardar GA, Khorramizadeh MR. Study of curcumin immunomodulatory effects on reactive astrocyte cell function. Int Immunopharmacol. 2014 Sep;22(1):230-5. doi: 10.1016/j.intimp.2014.06.035. Epub 2014 Jul 3. PMID 24998635
  • Results publication: Anthwal A, Thakur BK, Rawat MS, Rawat DS, Tyagi AK, Aggarwal BB. Synthesis, characterization and in vitro anticancer activity of C-5 curcumin analogues with potential to inhibit TNF-alpha-induced NF-kappaB activation. Biomed Res Int. 2014;2014:524161. doi: 10.1155/2014/524161. Epub 2014 Jul 24. PMID 25157362
  • Results publication: Esatbeyoglu T, Huebbe P, Ernst IM, Chin D, Wagner AE, Rimbach G. Curcumin--from molecule to biological function. Angew Chem Int Ed Engl. 2012 May 29;51(22):5308-32. doi: 10.1002/anie.201107724. Epub 2012 May 4. PMID 22566109
  • Results publication: McCoy LC, Wehler CJ, Rich SE, Garcia RI, Miller DR, Jones JA. Adverse events associated with chlorhexidine use: results from the Department of Veterans Affairs Dental Diabetes Study. J Am Dent Assoc. 2008 Feb;139(2):178-83. doi: 10.14219/jada.archive.2008.0134. PMID 18245686
  • Results publication: Yin Y, Shuai F, Liu X, Zhao Y, Han X, Zhao H. Biomaterials and therapeutic strategies designed for tooth extraction socket healing. Biomaterials. 2025 May;316:122975. doi: 10.1016/j.biomaterials.2024.122975. Epub 2024 Nov 29. PMID 39626339

+Investigators

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