Alveolar OsteitisPhase 2NCT05850650
The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis
A Phase 2 study testing Application of a collagen sponge after surgical extraction of impacted 3rd molar and No collagen sponge application after surgical extraction of impacted 3rd molar in people with Alveolar Osteitis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Application of a collagen sponge after surgical extraction of impacted 3rd molar and No collagen sponge application after surgical extraction of impacted 3rd molar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2023to 15 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
RiyadH Colleges of dentistry and Pharmacy
Riyadh, 11681
About this study
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
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?
- Conditions
- Alveolar Osteitis
- Being tested
- Application of a collagen sponge after surgical extraction of impacted 3rd molar, No collagen sponge application after surgical extraction of impacted 3rd molar
- Keywords
- alveolar osteitis, Collagen sponge, Impacted lower third molar
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a collagen sponge after surgical extraction of impacted 3rd molarOther
Application of a collagen sponge after surgical extraction of impacted 3rd molar
No collagen sponge application after surgical extraction of impacted 3rd molarOther
No collagen sponge application after surgical extraction of impacted 3rd molar
| Study group | Role | What they receive |
|---|---|---|
| Controlled | Active comparator | The extraction socket will not receive a collagen sponge Receives: Other: No collagen sponge application after surgical extraction of impacted 3rd molar |
| Collagen | Experimental | The extraction socket will receive a collagen sponge Receives: Other: Application of a collagen sponge after surgical extraction of impacted 3rd molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-extraction Pain score
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Measured: 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
Measured: Pre-extraction
Pre-extraction Mouth opening
Maximum Mouth opening is taken by a caliber
Measured: Pre-extraction
Pain score Day3
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Measured: 3 days after extraction
Pain score Day7
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Measured: 7 days after extraction
Mouth opening Day7
Maximum Mouth opening is taken by a caliber
Measured: 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
Measured: 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
Measured: After 3 days of extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 May 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nedal Abu-Mostafa, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Nedal A Abu-Mostafa, Assistant P, Principal investigator, nabumostafa@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850650
- Sponsor's protocol ID
- REU
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be available in the published manuscript
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05850650
- Acronym / sponsor ID
- REU
- Conditions
- Alveolar Osteitis
- Keywords
- alveolar osteitis, Collagen sponge, Impacted lower third molar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Controlled | Active comparator | Other: No collagen sponge application after surgical extraction of impacted 3rd molarThe extraction socket will not receive a collagen sponge |
| Collagen | Experimental | Other: Application of a collagen sponge after surgical extraction of impacted 3rd molarThe extraction socket will receive a collagen sponge |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of a collagen sponge after surgical extraction of impacted 3rd molarApplication of a collagen sponge after surgical extraction of impacted 3rd molar | Other | Collagen |
| No collagen sponge application after surgical extraction of impacted 3rd molarNo collagen sponge application after surgical extraction of impacted 3rd molar | Other | Controlled |
Primary outcome
Pre-extraction Pain score
Time frame: Pre-extraction
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pre-extraction Halitosis
Time frame: 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
Time frame: Pre-extraction
Maximum Mouth opening is taken by a caliber
Pain score Day3
Time frame: 3 days after extraction
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pain score Day7
Time frame: 7 days after extraction
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Mouth opening Day7
Time frame: 7 days after extraction
Maximum Mouth opening is taken by a caliber
Halitosis Day7
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. It will be available in the published manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nedal A Abu-Mostafa, Assistant P principal investigator
nabumostafa@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Application of a collagen sponge after surgical extraction of impacted 3rd molar and No collagen sponge application after surgical extraction of impacted 3rd molar in people with Alveolar Osteitis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nedal A Abu-Mostafa, Assistant P (00966506275782, nabumostafa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-extraction Pain score (time frame: Pre-extraction). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.