Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • collagen membrane

    Procedure/Surgery

    collagen membrane apply to distal surface of second molar after third molar surgery

  • third molar surgery

    Procedure/Surgery

    standard third molar surgery without any additional application

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: studyExperimental treatment 1 intervention
Group B: controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Distal periodontal tissue status

distal periodontal tissue status was assessed using variables of pocket depth

Time frame
preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)

Secondary outcomes

1

Distal bone level

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

Time frame
at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).

Other outcomes

1

Postoperative pain

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.

Time frame
on the 1st, 3rd, 7th day after surgery
2

Postoperative swelling

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.

Time frame
on the 1st, 3rd, 7th day after surgery
3

Soft tissue healing

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.

Time frame
on the 7th day after surgery

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