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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05850650
Enrollment
40
Registered
2023-05-09
Start date
2023-05-01
Completion date
2023-11-15
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Osteitis

Keywords

alveolar osteitis, Collagen sponge, Impacted lower third molar

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?

Interventions

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

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

OTHERNo collagen sponge application after surgical extraction of impacted 3rd molar

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

Sponsors

Riyadh Colleges of Dentistry and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pre-extraction Pain scorePre-extractionPain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pre-extraction HalitosisPre-extractionHalitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Pre-extraction Mouth openingPre-extractionMaximum Mouth opening is taken by a caliber
Pain score Day33 days after extractionPain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pain score Day77 days after extractionPain measurement by VAS (0-10). 0: no pain. 10: worst pain
Mouth opening Day77 days after extractionMaximum Mouth opening is taken by a caliber
Halitosis Day77 days after extractionHalitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Alveolar osteitisAfter 3 days of extractionis 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

Countries

Saudi Arabia

Contacts

Primary ContactNedal A Abu-Mostafa, Assistant P
nabumostafa@gmail.com00966506275782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026