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

Phase 2
Not yet recruiting
Conditions
Alveolar Osteitis
Interventions
Other: No collagen sponge application after surgical extraction of impacted 3rd molar
Other: Application of a collagen sponge after surgical extraction of impacted 3rd molar
Registration Number
NCT05850650
Lead Sponsor
Riyadh Colleges of Dentistry and Pharmacy
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?

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlledNo collagen sponge application after surgical extraction of impacted 3rd molarThe extraction socket will not receive a collagen sponge
CollagenApplication of a collagen sponge after surgical extraction of impacted 3rd molarThe extraction socket will receive a collagen sponge
Primary Outcome Measures
NameTimeMethod
Pre-extraction Pain scorePre-extraction

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

Pain score Day33 days after extraction

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

Halitosis Day77 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 HalitosisPre-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 openingPre-extraction

Maximum Mouth opening is taken by a caliber

Mouth opening Day77 days after extraction

Maximum Mouth opening is taken by a caliber

Alveolar osteitisAfter 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 Day77 days after extraction

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

RiyadH Colleges of dentistry and Pharmacy

🇸🇦

Riyadh, Saudi Arabia

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