A Phase 2 interventional study of 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 Alveolar Osteitis, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Phase 2, Interventional, and Treatment
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?
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 41 interventional studies indexed under Dry Socket.
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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 , pregnant women, breastfeeding women, and those who were using oral .
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The extraction socket will not receive a collagen sponge
Other: No collagen sponge application after surgical extraction of impacted 3rd molar
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
No collagen sponge application after surgical extraction of impacted 3rd molar
Pre-extraction Pain score
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Time frame: 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
Time frame: Pre-extraction
Pre-extraction Mouth opening
Maximum Mouth opening is taken by a caliber
Time frame: Pre-extraction
Pain score Day3
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Time frame: 3 days after extraction
Pain score Day7
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Time frame: 7 days after extraction
Mouth opening Day7
Maximum Mouth opening is taken by a caliber
Time frame: 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
Time frame: 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
Time frame: After 3 days of extraction
Plan to share: No — It will be available in the published manuscript
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Riyadh Colleges of Dentistry and Pharmacy