University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City, Vietnam
Location status: Recruiting
Recruiting
NCT Number: NCT07114523
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Impacted mandibular third molars can cause various complications to the adjacent second molars, such as dental caries, periodontitis, or root resorption. These complications often progress silently and asymptomatically. A typical scenario involves a mesioangularly impacted third molar exerting pressure on the distal alveolar bone of the second molar, resulting in persistent food impaction that is difficult for patients to clean. Furthermore, the surgical removal of deeply impacted or severely angulated mandibular third molars often requires bone removal in the area adjacent to the second molar. These factors may exacerbate distal periodontal defects of the second molar, especially in individuals over the age of 25. This research focuses on evaluating the effectiveness of a new-generation collagen membrane in promoting healing after the extraction of impacted mandibular third molars in patients at risk of distal periodontal tissue damage to the second molars
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
25 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients aged 25 years or older.
- Patients with mesioangular or horizontally impacted mandibular third molars. The highest point of mandibular third molars are lower than the occlusal surface of adjacent second molars (classified B, C according to Pell - Gregory's category).
- Patients with symmetrical lower third molars on both sides with same classification according to Pell - Gregory's category. The difference of third molars inclination on both side is not more than 15°.
- Patients with lower second molars on both sides have no cavities or fillings that affect the determination of the cemento-enamel junction.
- Patients are explained, counseled clearly and sign their consent to participate in the study.
Exclusion criteria
- Patients with coagulation or immune disorders.
- Patients allergic to local anesthetics (Lidocaine 2% with Adrenaline 1:100,000) or any drugs used in the study.
- Patients allergic to products or food derived from pigs.
- Pregnant or breastfeeding patients.
- Patients who smoke.
- Patients with systemic conditions that contraindicate surgical procedures.
- Patients with clinical or radiographic signs suggestive of tumors (benign or malignant) associated with or in proximity to the mandibular third molar.
- Patients with missing mandibular second molars.
Treatment and study plan
Collagen membrane
Procedurecollagen membrane apply to distal surface of second molar after third molar surgery
Third molar surgery
Procedurestandard third molar surgery without any additional application
Primary outcomes
-
Distal periodontal tissue status
Time frame: preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)
distal periodontal tissue status was assessed using variables of pocket depth
Secondary outcomes
-
Distal bone level
Time frame: at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).
The variable was determined by measuring the distance from the CEJ of mandibular second molar to the highest point of the alveolar crest, performed with the periapical radiograph using the parallel technique, standardized with a film holder and a stent with a 5 mm steel segment
Other outcomes
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Postoperative pain
Time frame: on the 1st, 3rd, 7th day after surgery
Postoperative pain was assessed by patient using the VAS (Visual Analog Scale) on the 1st, 3rd, 7th day after surgery. The VAS pain assessment scale is a 100 mm long line with 2 endpoints defined as "no pain" on the left side and "maximum pain" on the right side. The patient will record his/her pain level by marking a point on the line, the pain point will be the distance measured from the left endpoint to the point marked by patient.
-
Postoperative swelling
Time frame: on the 1st, 3rd, 7th day after surgery
Facial swelling was assessed by the patient using the modified VAS scale of Pasqualini et al (2005) on the 1st, 3rd, 7th day after surgery. The scale consisted of 6 levels from 0 (no swelling) to 5 (severe swelling), patient will choose the corresponding level of swelling.
-
Soft tissue healing
Time frame: on the 7th day after surgery
Soft tissue healing was assessed using Healing index of Landry, Turnbull, and Howley on the 7th day after surgery. The scale consists of 5 grades, from grade 1 (very poor healing) to grade 5 (excellent healing) based on signs of tissue color, bleeding, presence of granulation tissue, presence of pus, and degree of epithelialization.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Other
Registry information
Official study title
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Aug 11, 2025
- Registry last updated
- Aug 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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