The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis

Study Overview
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Brief Summary
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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?

Official Title
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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

Conditions
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Alveolar Osteitis

Intervention / Treatment
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* Other: Application of a collagen sponge after surgical extraction of impacted 3rd molar
* Other: No collagen sponge application after surgical extraction of impacted 3rd molar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Controlled<br>The extraction socket will not receive a collagen sponge | Other: No collagen sponge application after surgical extraction of impacted 3rd molar<br>* No collagen sponge application after surgical extraction of impacted 3rd molar<br>|
| Experimental: Collagen<br>The extraction socket will receive a collagen sponge | Other: Application of a collagen sponge after surgical extraction of impacted 3rd molar<br>* Application of a collagen sponge after surgical extraction of impacted 3rd molar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-extraction Pain score | Pain measurement by VAS (0-10). 0: no pain. 10: worst pain | Pre-extraction | 
| Pre-extraction Halitosis | Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech | Pre-extraction | 
| Pre-extraction Mouth opening | Maximum Mouth opening is taken by a caliber | Pre-extraction | 
| Pain score Day3 | Pain measurement by VAS (0-10). 0: no pain. 10: worst pain | 3 days after extraction | 
| Pain score Day7 | Pain measurement by VAS (0-10). 0: no pain. 10: worst pain | 7 days after extraction | 
| Mouth opening Day7 | Maximum Mouth opening is taken by a caliber | 7 days after extraction | 
| Halitosis Day7 | Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech | 7 days after extraction | 
| Alveolar osteitis | 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 | After 3 days of extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impacted lower third molar, alveolar osteitis, Collagen sponge