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Clinical Trials/NCT05850650
NCT05850650
Not yet recruiting
Phase 2

The Effect of Collagen Sponge Placed in the Socket After Surgical Extraction of Mandibular Third Molars on the Incidence of Alveolar Osteitis. A Randomized Controlled Trial

Riyadh Colleges of Dentistry and Pharmacy1 site in 1 country40 target enrollmentMay 1, 2023

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Alveolar Osteitis
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
Enrollment
40
Locations
1
Primary Endpoint
Pre-extraction Pain score
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this randomized controlled trial is to compare pain, mouth opening, and alveolar osteitis following surgical extraction of bilateral symmetrical impacted lower third molars using two types of wound closures. Collagen plugs will be applied in the sockets of the study side followed by suture, while the controlled side will be sutured without a collagen plug. The study will include 40 patients aged between 18- 40 years old, medically fit (ASA1), who have bilateral symmetrical impacted lower third molars and visit the oral surgery clinics of King Saud Medical City for extraction. The main question is" Does intra-alveolar collagen application after surgical extraction of impacted lower third molars reduce the incidence of alveolar osteitis?

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
November 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Riyadh Colleges of Dentistry and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Nedal Abu-Mostafa

Assistant Professor in Oral and Maxillofacial Surgery

Riyadh Colleges of Dentistry and Pharmacy

Eligibility Criteria

Inclusion Criteria

  • Forty patients aged between 18- 40 years old, ASA1, who have bilateral symmetrical impacted lower third molars and visit the oral surgery clinics of King Saud Medical City for extraction.

Exclusion Criteria

  • Uncontrolled systemic diseases, diabetes, bone diseases, smokers, epinephrine contraindications, pregnant women, breastfeeding women, and those who were using oral contraceptives.
  • Other exclusion criteria are the presence of acute infection and facial swelling, cystic lesions, and TMJ problems. Moreover, any surgical extraction that lasts more than 30 minutes +/- 5 minutes, or has been done without the whole standardized steps will be excluded.

Outcomes

Primary Outcomes

Pre-extraction Pain score

Time Frame: Pre-extraction

Pain measurement by VAS (0-10). 0: no pain. 10: worst pain

Pain score Day3

Time Frame: 3 days after extraction

Pain measurement by VAS (0-10). 0: no pain. 10: worst pain

Halitosis Day7

Time Frame: 7 days after extraction

Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech

Pre-extraction Mouth opening

Time Frame: Pre-extraction

Maximum Mouth opening is taken by a caliber

Pre-extraction Halitosis

Time Frame: Pre-extraction

Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech

Mouth opening Day7

Time Frame: 7 days after extraction

Maximum Mouth opening is taken by a caliber

Alveolar osteitis

Time Frame: After 3 days of extraction

is diagnosed if the patient complains of pain (more than 5) between day 2 and day 4 with empty sockets and food debris, with or without halitosis

Pain score Day7

Time Frame: 7 days after extraction

Pain measurement by VAS (0-10). 0: no pain. 10: worst pain

Study Sites (1)

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