NCT05850650

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

May 9, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

March 19, 2023

Last Update Submit

April 30, 2023

Conditions

Alveolar Osteitis

Keywords

alveolar osteitisCollagen spongeImpacted lower third molar

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Controlled

ACTIVE COMPARATOR

The extraction socket will not receive a collagen sponge

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

Collagen

EXPERIMENTAL

The extraction socket will receive a collagen sponge

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

Interventions

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

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

Collagen
No collagen sponge application after surgical extraction of impacted 3rd molarOTHER

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

Controlled

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Uncontrolled systemic diseases, diabetes, bone diseases, smokers, epinephrine contraindications, pregnant women, breastfeeding women, and those who were using oral contraceptives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RiyadH Colleges of dentistry and Pharmacy

Riyadh, 11681, Saudi Arabia

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Nedal A Abu-Mostafa, Assistant P

    nabumostafa@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nedal A Abu-Mostafa, Assistant P

CONTACT

00966506275782nabumostafa@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants (patients) will not be informed about which side will recieve the collagen
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

March 19, 2023

First Posted

May 9, 2023

Study Start

May 1, 2023

Primary Completion

October 15, 2023

Study Completion

November 15, 2023

Last Updated

May 9, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

It will be available in the published manuscript

Locations

SA(1)