- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07723326
Comparison of Electrocautery and Scalpel Blade Incisions of Impacted Mandibular Third Molars
Comparison of Electrocautery and Scalpel Blade Incisions on Postoperative Pain, Intraoperative Blood Loss, and Wound Healing Following Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Surgical extraction of impacted mandibular third molars is one of the most common procedures in oral and maxillofacial surgery. The type of incision used may influence postoperative outcomes, including pain, bleeding, and wound healing. Electrocautery offers simultaneous cutting and coagulation, potentially reducing intraoperative blood loss and improving surgical visibility, whereas scalpel incisions produce precise tissue cuts without thermal injury.
This prospective, two-arm, parallel-group, randomized controlled trial will compare electrocautery and scalpel blade incisions in patients undergoing surgical extraction of impacted mandibular third molars. Seventy-eight participants will be randomly assigned to either Arm A (scalpel blade incision) or Arm B (electrocautery incision). All other surgical and perioperative variables, including local anesthesia, flap design, irrigation, suture material, and postoperative medications, will be standardized.
The primary outcome is postoperative pain assessed using a Visual Analogue Scale at 24 hours, 48 hours, and 7 days. Secondary outcomes include intraoperative blood loss and wound healing assessed using the Landry Wound Healing Index at 1 and 4 weeks. The findings of this study will provide evidence regarding the most appropriate incision technique for impacted mandibular third-molar surgery.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Muhammad Usama, BDS/FCPS
- Telefonnummer: +923325595484
- E-mail: usamakhan123478@gmail.com
Undersøgelse Kontakt Backup
- Navn: Uzair Luqman, BDS/FCPS
- Telefonnummer: +923215080354
- E-mail: uzair.luqman@riphah.edu.pk
Studiesteder
-
-
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Islamabad, Pakistan, 44000
- Islamic International Dental Hospital
-
Kontakt:
- Muhammad Usama, BDS/FCPS
- Telefonnummer: +923325595484
- E-mail: usamakhan123478@gmail.com
-
Ledende efterforsker:
- Uzair Luqman, BDS/FCPS
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Male and female patients.
- Age 15 to 65 years.
- Patients requiring surgical extraction of an impacted mandibular third molar. Patients classified as ASA I or ASA II.
- Patients willing to provide written informed consent, or assent with parent/guardian permission where applicable, and attend scheduled follow-up visits
Exclusion Criteria:
* Patients with uncontrolled systemic disease or immuno-compromised status.
- Patients with bleeding disorders or those taking anticoagulant/antiplatelet drugs that cannot be safely withheld according to physician advice.
- Patients with pacemaker or implanted electrical cardiac device.
- Pregnant or lactating patients.
- Patients with acute infection, pericoronitis, facial space infection, or pus discharge at the surgical site at the time of surgery.
- Patients requiring bilateral third-molar extraction in the same sitting.
- Patients unwilling to participate or unable to return for follow-up.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: scalpel blade incision group
Participants will undergo surgical extraction of impacted mandibular third molars using a sterile No. 15 scalpel blade for the mucoperiosteal flap incision
|
A sterile No. 15 stainless-steel scalpel blade will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
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|
Eksperimentel: electrocautery incision group
Participants will undergo surgical extraction of impacted mandibular third molars using electrocautery in cutting mode for the mucoperiosteal flap incision
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A fine electrocautery electrode in cutting mode at a standardized effective power setting will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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postoperative pain
Tidsramme: 24 hours, 48 hours, and 7 days after surgery.
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Postoperative pain at the surgical site will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain
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24 hours, 48 hours, and 7 days after surgery.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
intraoperative blood loss
Tidsramme: During surgery (from first incision to final suture).
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Total blood loss will be calculated as the increase in gauze weight plus the suction-canister volume after subtracting the recorded irrigation volume.
Results will be reported in milliliters (mL).
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During surgery (from first incision to final suture).
|
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wound healing
Tidsramme: 1 week and 4 weeks after surgery.
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Wound healing will be assessed using the Landry Wound Healing Index, scored from 1 (very poor) to 5 (excellent).
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1 week and 4 weeks after surgery.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Uzair Luqman, BDS/FCPS, department of ORAL AND MAXILLOFACIAL SURGERY ISLAMIC INTERNATIONAL DENTAL HOSPITAL
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Andre undersøgelses-id-numre
- IIDC/IRC/2026/7/001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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