Periodontal Defect
Conditions
Brief summary
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
Interventions
PROCEDUREcollagen membrane
collagen membrane apply to distal surface of second molar after third molar surgery
PROCEDUREthird molar surgery
standard third molar surgery without any additional application
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This type of interventional study in dentistry is referred to as a split-mouth design. In this design, the intervention subjects have bilaterally symmetrical conditions within the oral cavity, allowing one side to serve as the intervention group while the contralateral side serves as the control group.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distal periodontal tissue status | 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
| Measure | Time frame | Description |
|---|---|---|
| Distal bone level | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 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 | 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 | 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. |
Countries
Vietnam
Contacts
Primary ContactPhong Cu Lam, MD.DDS
Outcome results
None listed