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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Osteitis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nedal A Abu-Mostafa, Assistant P; Phone Number: 00966506275782; Email: nabumostafa@gmail.com

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11681
    • Riyadh Colleges of Dentistry and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Controlled; The extraction socket will not receive a collagen sponge	Other: No collagen sponge application after surgical extraction of impacted 3rd molar; No collagen sponge application after surgical extraction of impacted 3rd molar
Experimental: Collagen; The extraction socket will receive a collagen sponge	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Nedal A Abu-Mostafa, Assistant P, nabumostafa@gmail.com

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): October 15, 2023
• Study Completion (Anticipated): November 15, 2023

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: April 30, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: alveolar osteitis; Collagen sponge; Impacted lower third molar
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Osteitis; Dry Socket
• Other Study ID Numbers: REU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be available in the published manuscript

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No