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

Sponsor

Riyadh Colleges of Dentistry and Pharmacy (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05850650

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Alveolar Osteitis	Other: Application of a collagen sponge after surgical extraction of impacted 3rd molar Other: No collagen sponge application after surgical extraction of impacted 3rd molar	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Nov 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pre-extraction Pain score [Pre-extraction]
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pre-extraction Halitosis [Pre-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 opening [Pre-extraction]
Maximum Mouth opening is taken by a caliber
Pain score Day3 [3 days after extraction]
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pain score Day7 [7 days after extraction]
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Mouth opening Day7 [7 days after extraction]
Maximum Mouth opening is taken by a caliber
Halitosis Day7 [7 days after extraction]
Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Alveolar osteitis [After 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RiyadH Colleges of dentistry and Pharmacy	Riyadh		Saudi Arabia	11681

Sponsors and Collaborators

Riyadh Colleges of Dentistry and Pharmacy

Investigators

Principal Investigator: Nedal A Abu-Mostafa, Assistant P, nabumostafa@gmail.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nedal Abu-Mostafa, Assistant Professor in Oral and Maxillofacial Surgery, Riyadh Colleges of Dentistry and Pharmacy

ClinicalTrials.gov Identifier:

NCT05850650

Other Study ID Numbers:

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Nedal Abu-Mostafa, Assistant Professor in Oral and Maxillofacial Surgery, Riyadh Colleges of Dentistry and Pharmacy

alveolar osteitis

Collagen sponge

Impacted lower third molar

Additional relevant MeSH terms:

Osteitis

Dry Socket

Study Results

No Results Posted as of May 9, 2023