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

Alveolar Osteitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850650
• Other study ID #: REU
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: April 2023
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: Nedal A Abu-Mostafa, Assistant P
• Phone: 00966506275782
• Email: nabumostafa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Osteitis
• Dry Socket
• Osteitis

Intervention

Other:
• Application of a collagen sponge after surgical extraction of impacted 3rd molar
Application of a collagen sponge after surgical extraction of impacted 3rd molar
• No collagen sponge application after surgical extraction of impacted 3rd molar
No collagen sponge application after surgical extraction of impacted 3rd molar

Locations

Country	Name	City	State
Saudi Arabia	RiyadH Colleges of dentistry and Pharmacy	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-extraction Pain score	Pain measurement by VAS (0-10). 0: no pain. 10: worst pain	Pre-extraction
Primary	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
Primary	Pre-extraction Mouth opening	Maximum Mouth opening is taken by a caliber	Pre-extraction
Primary	Pain score Day3	Pain measurement by VAS (0-10). 0: no pain. 10: worst pain	3 days after extraction
Primary	Pain score Day7	Pain measurement by VAS (0-10). 0: no pain. 10: worst pain	7 days after extraction
Primary	Mouth opening Day7	Maximum Mouth opening is taken by a caliber	7 days after extraction
Primary	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
Primary	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