- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07936812
Topical Corticosteroid and Wound Healing After Periodontal Flap Surgery
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
Status
Betingelser
Intervention / Behandling
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
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Meral UZUNKAYA, ASSISTANT PROFESSOR
- Telefonnummer: +903443003824
- E-post: meraluzunkaya@ksu.edu.tr
Studieorter
-
-
-
Kahramanmaraş, Turkiet (Türkiye)
- Rekrytering
- Kahramanmaras Sutcu Imam University, Faculty of Dentistry
-
Kontakt:
- Meral UZUNKAYA, ASSISTANT PROFESSOR
- Telefonnummer: +903443003824
- E-post: meraluzunkaya@ksu.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
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
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:
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
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Parodontala sjukdomar
- Munsjukdomar
- Stomatogena sjukdomar
- Postoperativa komplikationer
- Patologiska processer
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Smärta, postoperativt
- Parodontit
- Farmaceutiska förberedelser
- Doseringsformer
- Polycykliska föreningar
- Triamcinolon
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Steroider, fluorerade
- Triamcinolonacetonid
- Salva
Andra studie-ID-nummer
- PFK-2026-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .