The effects of grafting with dental biomaterials on the tooth-supporting tissues surrounding lower second molars following removal of impacted third molars in healthy young adults
Bio-Oss Collagen grafting and the periodontal attachment effects following extraction of mesioangular, impacted third molars in medically healthy and periodontally sound 18 - 35 year old adults.
The University Of Queensland
36 participants
Aug 1, 2020
Interventional
Conditions
Summary
Impacted mandibular third molars can cause extensive damage to the bone and supporting structures (known as the periodontal attachment) surrounding the adjacent second molar. This clinical trial is conducting research on the benefits of ridge preservation, also known as socket grafting, carried out at the time of extraction of an impacted mandibular third molar provides any additional periodontal attachment. In many cases after a tooth extraction, soft tissue and bone grows into the site to facilitate healing and the formation of periodontal tissue to support the adjacent second molar. However, in some cases the healing does not proceed as desired and there are inadequate amounts of periodontal attachment. This means that the bone and tissue support around the adjacent molar is compromised and the tooth has an increased risk of being lost prematurely. Bone substitute materials have been widely used for socket grafting and periodontal regenerate procedures for more than 15 years. Geistlich Bio-Oss Collagen® supports the body’s own bone regenerative processes extremely effectively and help guide hard tissue formation following tooth extraction. Bio-Oss Collagen® consist of 90% Bio-Oss® with 10% porcine collagen. Bio-Oss® is derived from the bone of an Australian bovine herd around Melbourne. The bones are transported to Switzerland for treatment either by heat, chemicals or both to remove all organic components. Porcine collagen is added as part of this process to provide some dimensional stability. Bio-Oss Collagen® is made under a strictly controlled manufacturing process. Due to the great similarity to human tissue, these materials are optimally suited and widely used clinically to promote new bone formation and tissue healing in the human body. Current treatment following an extraction involves healing by blood clot with or without placement of sutures to stabilize the blood clot. Recent evidence suggests that the application of Bio-Oss Collagen® might help assist the healing process to reform the desired levels of bone, gum and periodontal supporting tissue. We are interested in whether socket grafting with Bio-Oss Collagen® will help bone, gum and periodontal tissue formation around the adjacent, remaining tooth compared to standard extraction protocols. This will result in a greater amount of periodontal tissue supporting the adjacent tooth and reduce the risk of premature tooth loss. We are particularly interested in healthy 18 – 35 years old subjects.
Eligibility
Inclusion Criteria5
- One or two unerupted mandibular third molars that are Class I or II and Position B or C on the Pell and Gregory scale with a Horizontal or Mesioangular (10-80 degrees) of the Winter classification
- Evidence of radiographic bone loss of more than 5mm from the cementoenamel junction to the crest of the alveolar bone on the distal aspect of the distal root of the adjacent second molar at time of initial examination due to an impacted wisdom tooth
- Able to tolerate extraction procedure: surgeon will determine this parameter
- Medically fit and well. Classified as American Society of Anaesthesiologist (ASA) Class I patient as a normal, healthy patient. (no medical illness e.g. diabetes, not smoking, low alcohol intake)
- Aged 18 – 45 years old
Exclusion Criteria7
- Impacted third molars that are disto-angular impacted or require extensive surgery
- Patient has a history of diagnosed periodontitis disease (more than 2mm of clinical attachment loss)
- Patient currently has periodontal disease in any aspect of the mouth except periodontal breakdown associated with impacted third molars (mandibular or maxillary)
- Patient has lost more than 2mm of clinical attachment due to non-periodontal reasons
- Pathology that requires more than just extraction and primary wound closure
- Plaque index of 40% or more (indicating poor oral hygiene)
- Patients unwilling to return for all periodontal review appointment
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Interventions
Tooth extraction and ridge preservation will be performed by the specialist oral and maxillofacial surgeon (under local or general anaesthesia) using a minimally traumatic approached aimed to preserve an intact buccal bony cortex. If necessary, roots will be sectioned with a bur and removed separately to minimize damage to the bony cortex. Careful curettage of the socket will be performed to remove all bony and tooth debris and infective tissue and exposed tooth structure of the adjacent tooth will be debrided. It is anticipated that extracting both third molars will take approximately 45 minutes of surgical time. Once both third mandibular third molars have been removed, the surgeon will then open a sealed envelope indicating which side (left or right) is receiving the grafting procedure (test site) and which site is receiving no additional treatment (control site). In test sites, the extraction socket will be grafted with Bio-Oss Collagen which will be firmly compacted and secured against the exposed root, cemento-enamel junction and approximately one millimetre above the junction. This will take approximately one minute of surgical time and the study intervention is completed at this time. Both test and control sites will be closed by primary flap closure where possible and secured with sutures. The surgeon will discuss post-operative antibiotic and analgesic therapy with each patient. Subjects will be instructed to avoid rinsing and spitting for the first twenty-four hours. Subjects will be advised to use zero-point two percent chlorhexidine mouth wash for rinsing twice daily and to avoid brushing directly on the surgical site for one week. Subjects will be advised to maintain a soft diet for two weeks. Patients will be reviewed in approximately two weeks (or similar timeframe as required by the surgeon) and sutures will be removed. Any incidence of postoperative complications will be recorded and can be compared between control and test groups. Final clinical and radiographic measures will be taken six months after the surgery.
Locations(1)
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ACTRN12620000497909