- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Ankara, Tyrkia (Türkiye), 06560
- Ankara University Faculty of Dentistry
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 inngripen: Control socket
The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mehmet Emre Yurttutan, PhD, DDS, Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 36290600/51
Plan for individuelle deltakerdata (IPD)
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