Clinical trial NCT05850650: The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alveolar Osteitis
Keywords: alveolar osteitis
Collagen sponge
Impacted lower third molar
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will have surgical extraction of impacted 3rd molars for both sides with a gap of 3 weeks. The study side will receive a collage sponge after extraction followed by sutures. The controlled side will have sutures without a collagen sponge.
Primary purpose: TREATMENT

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?


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.

Primary outcomes:
measure: Pre-extraction Pain score
timeFrame: Pre-extraction
measure: Pre-extraction Halitosis
timeFrame: Pre-extraction
measure: Pre-extraction Mouth opening
timeFrame: Pre-extraction
measure: Pain score Day3
timeFrame: 3 days after extraction
measure: Pain score Day7
timeFrame: 7 days after extraction
measure: Mouth opening Day7
timeFrame: 7 days after extraction
measure: Halitosis Day7
timeFrame: 7 days after extraction
measure: Alveolar osteitis
timeFrame: After 3 days of extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: RiyadH Colleges of dentistry and Pharmacy
Study officials:
affiliation: nabumostafa@gmail.com
name: Nedal A Abu-Mostafa, Assistant P
role: PRINCIPAL_INVESTIGATOR
References: