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Topical Corticosteroid and Wound Healing After Periodontal Flap Surgery

7 november 2026 uppdaterad av: Meral Uzunkaya, Kahramanmaras Sutcu Imam University

Effect of Topical Corticosteroid Application on Early Wound Healing After Periodontal Flap Surgery: A Randomized Split-Mouth Clinical Trial

This randomized split-mouth clinical trial aims to evaluate the effect of topical corticosteroid application on postoperative wound healing and pain following periodontal flap surgery in patients with periodontitis. Forty participants requiring bilateral periodontal flap surgery in the maxilla will be included. In each participant, one surgical site will be randomly assigned to receive topical triamcinolone acetonide 0.1% after surgery, while the contralateral site will serve as the control and will receive periodontal flap surgery without topical corticosteroid application. Wound healing, postoperative pain, and periodontal probing depth will be evaluated during the follow-up period.

Studieöversikt

Detaljerad beskrivning

Periodontitis is a chronic inflammatory disease that may require periodontal flap surgery when adequate treatment outcomes cannot be achieved with non-surgical periodontal therapy alone. Postoperative pain and early wound healing are important factors affecting patient comfort and recovery following periodontal surgery. Topical corticosteroids have anti-inflammatory properties and are widely used for various inflammatory conditions of the oral mucosa; however, evidence regarding their use following periodontal flap surgery is limited.

This prospective, randomized, controlled, split-mouth clinical trial will evaluate the effect of a single topical application of triamcinolone acetonide 0.1% following periodontal flap surgery. Forty patients with periodontitis who require bilateral periodontal flap surgery in the maxilla will be enrolled.

Each participant will undergo periodontal flap surgery at two contralateral maxillary sites in separate surgical sessions. Using random allocation, one site will receive topical triamcinolone acetonide 0.1% following suturing, whereas the contralateral site will undergo the same surgical procedure without topical corticosteroid application and will serve as the control. Thus, each participant will serve as their own control.

Postoperative wound healing and pain will be evaluated during follow-up, together with changes in periodontal probing depth. The split-mouth design is intended to reduce the influence of interindividual variability when comparing the two treatment conditions.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

      • Kahramanmaraş, Turkiet (Türkiye)
        • Rekrytering
        • Kahramanmaras Sutcu Imam University, Faculty of Dentistry
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Aged 18 years or older Systemically healthy Diagnosed with periodontitis Requiring bilateral periodontal flap surgery in the maxilla Presence of comparable contralateral maxillary surgical sites suitable for a split-mouth design Willing and able to provide written informed consent For female participants, postmenopausal status

Exclusion Criteria:

  • Women of childbearing potential Pregnant or lactating women Current smokers Presence of systemic diseases or conditions that may affect periodontal wound healing Use of medications that may affect periodontal tissues or wound healing Inability or unwillingness to comply with the study procedures and scheduled follow-up visits

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Topical Triamcinolone

Participants will undergo open flap debridement (OFD) at the randomly assigned test site in the maxilla. Following completion of the surgical procedure and suturing, 0.1% triamcinolone acetonide will be applied topically to the surgical site as a single application. Each participant will also receive the control intervention at the contralateral maxillary site in a separate surgical session.

A single topical application of 0.1% triamcinolone acetonide will be administered to the randomly assigned experimental surgical site following completion of open flap debridement and suturing.

Andra namn:
  • Kenacort-A Orabase

Open flap debridement (OFD) will be performed at the periodontal surgical site. The surgical procedure will be performed at both the experimental and control sites in separate surgical sessions.

Aktiv komparator: Control

Participants will undergo open flap debridement (OFD) at the contralateral maxillary control site without topical corticosteroid application. Each participant will also receive the experimental intervention at the opposite maxillary site in a separate surgical session.

Open flap debridement (OFD) will be performed at the periodontal surgical site. The surgical procedure will be performed at both the experimental and control sites in separate surgical sessions.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Early Wound Healing Index (EHI)
Tidsram: Postoperative days 7, 14, and 45 after each surgical procedure.

Postoperative wound healing will be assessed using the Early Wound Healing Index (EHI) at the surgical sites. The index evaluates early healing of the surgical wound based on clinical characteristics of the incision line.

Postoperative days 7, 14, and 45 after each surgical procedure.
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Tidsram: Postoperative days 7, 14, and 45 after each surgical procedure.

Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will rate their pain intensity on a 0-10 scale, where 0 represents no pain and 10 represents the worst imaginable pain. VAS scores will be compared between the topical triamcinolone and control surgical sites.

Postoperative days 7, 14, and 45 after each surgical procedure.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Periodontal Probing Depth (PPD)
Tidsram: Baseline and postoperative day 45 after each surgical procedure.

Periodontal probing depth (PPD) will be measured in millimeters using a periodontal probe. Changes in PPD will be evaluated by comparing baseline measurements with postoperative measurements at the surgical sites.

Baseline and postoperative day 45 after each surgical procedure.

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

7 november 2026

Först inskickad som uppfyllde QC-kriterierna

7 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 november 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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