- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07604584
Effects of Platelet-Rich Fibrin After Mandibular Third Molar Surgery in Smokers and Nonsmokers
Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus and Swelling After Impacted Mandibular Third Molar Surgery in Smokers and Nonsmokers: A Prospective Clinical Study
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
This prospective randomized split-mouth clinical trial was conducted between 2017 and 2019 at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University. The study aimed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smoking and nonsmoking patients.
A total of 30 systemically healthy patients aged 18-35 years with bilaterally impacted mandibular third molars were included. Patients were divided into smoking and nonsmoking groups. In each patient, PRF was randomly applied to one extraction socket, while the contralateral socket served as the control site without PRF application. All surgical procedures were performed by the same oral and maxillofacial surgeon using a standardized surgical protocol. Outcome assessments were performed by a different clinician blinded to the intervention side.
Postoperative pain was evaluated using a visual analog scale (VAS). Facial swelling was assessed using linear facial measurements between anatomical landmarks, and trismus was evaluated by measuring maximum interincisal distance. Clinical evaluations were performed preoperatively and on postoperative days 1, 2, 3, and 7.
The primary outcome of the study was postoperative pain intensity. Secondary outcomes included postoperative swelling, trismus, and analgesic consumption. The study also aimed to compare the clinical effectiveness of PRF between smokers and nonsmokers.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Ankara, Tyrkiet (Türkiye), 06560
- Ankara University Faculty of Dentistry
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Systemically healthy patients aged between 18 and 35 years
- Bilaterally impacted mandibular third molars
- Mandibular third molars classified as Pell and Gregory Class I, Position C
- Mandibular third molars classified as Parant Class II difficulty
- Smoking and nonsmoking patients
- Patients willing to participate and provide written informed consent
Exclusion Criteria:
- Presence of acute infection or pericoronitis
- Pregnancy or lactation
- Alcohol or substance abuse
- Use of oral contraceptives
- Menstrual period during surgery
- Antibiotic use within the previous month
- Smoking more than 10 cigarettes per day
- Agitation or inability to cooperate
- Incomplete follow-up data
- Systemic disease contraindicating oral surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: PRF-treated socket
Platelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery.
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Autologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction.
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Ingen indgriben: Control socket
The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Intensity
Tidsramme: Postoperative days 1, 2, 3, and 7
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Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.
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Postoperative days 1, 2, 3, and 7
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Facial Swelling
Tidsramme: Preoperative period and postoperative days 1, 2, 3, and 7
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Postoperative facial swelling assessed using linear facial measurements between anatomical landmarks.
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Preoperative period and postoperative days 1, 2, 3, and 7
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Postoperative Trismus
Tidsramme: Preoperative period and postoperative days 1, 2, 3, and 7
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Trismus assessed by measuring maximum interincisal mouth opening distance.
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Preoperative period and postoperative days 1, 2, 3, and 7
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Postoperative Analgesic Consumption
Tidsramme: Postoperative days 1, 2, 3, and 7
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Number of analgesic tablets used during the postoperative follow-up period.
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Postoperative days 1, 2, 3, and 7
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mehmet Emre Yurttutan, PhD, DDS, Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 36290600/51
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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