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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-11-15

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?

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Detailed Description

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Conditions

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Alveolar Osteitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The participants (patients) will not be informed about which side will recieve the collagen

Study Groups

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Controlled

The extraction socket will not receive a collagen sponge

Group Type ACTIVE_COMPARATOR

No collagen sponge application after surgical extraction of impacted 3rd molar

Intervention Type OTHER

No collagen sponge application after surgical extraction of impacted 3rd molar

Collagen

The extraction socket will receive a collagen sponge

Group Type EXPERIMENTAL

Application of a collagen sponge after surgical extraction of impacted 3rd molar

Intervention Type OTHER

Application of a collagen sponge after surgical extraction of impacted 3rd molar

Interventions

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No collagen sponge application after surgical extraction of impacted 3rd molar

Intervention Type OTHER

Application of a collagen sponge after surgical extraction of impacted 3rd molar

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes