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

Primary Purpose

Alveolar Osteitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Application of a collagen sponge after surgical extraction of impacted 3rd molar
No collagen sponge application after surgical extraction of impacted 3rd molar
Sponsored by
Riyadh Colleges of Dentistry and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Osteitis focused on measuring alveolar osteitis, Collagen sponge, Impacted lower third molar

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • RiyadH Colleges of dentistry and Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Controlled

Collagen

Arm Description

The extraction socket will not receive a collagen sponge

The extraction socket will receive a collagen sponge

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 19, 2023
Last Updated
April 30, 2023
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT05850650
Brief Title
The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy

4. Oversight

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
Data Monitoring Committee
No

5. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis
Keywords
alveolar osteitis, Collagen sponge, Impacted lower third molar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
The participants (patients) will not be informed about which side will recieve the collagen
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Controlled
Arm Type
Active Comparator
Arm Description
The extraction socket will not receive a collagen sponge
Arm Title
Collagen
Arm Type
Experimental
Arm Description
The extraction socket will receive a collagen sponge
Intervention Type
Other
Intervention Name(s)
Application of a collagen sponge after surgical extraction of impacted 3rd molar
Intervention Description
Application of a collagen sponge after surgical extraction of impacted 3rd molar
Intervention Type
Other
Intervention Name(s)
No collagen sponge application after surgical extraction of impacted 3rd molar
Intervention Description
No collagen sponge application after surgical extraction of impacted 3rd molar
Primary Outcome Measure Information:
Title
Pre-extraction Pain score
Description
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Time Frame
Pre-extraction
Title
Pre-extraction Halitosis
Description
Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Time Frame
Pre-extraction
Title
Pre-extraction Mouth opening
Description
Maximum Mouth opening is taken by a caliber
Time Frame
Pre-extraction
Title
Pain score Day3
Description
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Time Frame
3 days after extraction
Title
Pain score Day7
Description
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Time Frame
7 days after extraction
Title
Mouth opening Day7
Description
Maximum Mouth opening is taken by a caliber
Time Frame
7 days after extraction
Title
Halitosis Day7
Description
Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Time Frame
7 days after extraction
Title
Alveolar osteitis
Description
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
Time Frame
After 3 days of extraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nedal A Abu-Mostafa, Assistant P
Phone
00966506275782
Email
nabumostafa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nedal A Abu-Mostafa, Assistant P
Organizational Affiliation
nabumostafa@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
RiyadH Colleges of dentistry and Pharmacy
City
Riyadh
ZIP/Postal Code
11681
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be available in the published manuscript

Learn more about this trial

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

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