Socket Preservation, Wisdom Tooth
Conditions
Keywords
bone substitutes, allplastic, alveolar ridge augmentation, periodontal defect
Brief summary
This study compared two bone graft materials: 1. Auto Tooth Bone (ATB) (made from the patient's own extracted tooth) and 2. EthOss® a synthetic alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving ATB and the other receiving EthOss®. Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays. The study found that both materials performed similarly and showing no significant differences in pain, swelling, complications, or gum healing. While there was a statistical difference in final bone depth. Both grafts successfully stimulated new bone growth, proving that ATB and EthOss® are equally safe, reliable, and effective options for supporting recovery after wisdom tooth surgery.
Detailed description
Surgical removal of impacted mandibular third molars may lead to complications that include periodontal defects at the second molar. Alveolar socket preservation with graft material can reduce this complication. This study aims to assess the soft and hard tissue healing of the surgical sites following the removal of impacted mandibular third molars with alveolar socket preservation using auto tooth bone graft (ATB) or EthOss® alloplastic graft and comparing for any difference between both grafts. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket filled with ATB or EthOss® alloplastic graft. The participants were reviewed 1 week and 4 weeks post-operative for signs of graft reaction/rejection. Periodontal assessments were performed at post-operative week 12 and 24 to assess the soft tissue healing. Radiological assessment was done at post-operative week 24 to assess bone depth. There was no significant difference between ATB and EthOss® graft in the healing of the soft tissue adjacent to the sockets, post-operative sequelae (pain, trismus and facial swelling) or post-operative complications. However, a statistically significant difference was observed in bone depth within both groups. The healing outcomes and bone quality achieved with ATB and EthOss® are comparable. Both materials have demonstrated effective osteoconductive properties, making them reliable materials for bone regeneration. This equivalency in clinical performance supports the use of either material as viable alternatives for bone regeneration procedures with predictable results.
Interventions
COMBINATION_PRODUCTauto tooth graft material
auto tooth graft (dentin graft) is taken from patient's extracted lower wisdom tooth. Ethoss is a synthetic material
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patient and surgeons are masking from the usage of different bone graft materials
Intervention model description
This is a split mouth study, within a single patient auto tooth graft and allograft (Ethoss) placed on each side of lower wisdom tooth socket.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient who requires surgical removal of bilateral impacted M3. * Patient with impacted bilateral M3 which are sound. * Impacted bilateral M3 classified as Class I or II with Level A or B according to Pell and Gregory's classification. * Presence of M2 adjacent to the M3 to be extracted. * Patient aged 18 to 35 years old. * Patient with periodontal status of: * Basic Periodontal Score (BPE) 2 at lower right and lower left sextants. * Full mouth plaque score \<30%.
Exclusion criteria
* Impacted M3 associated in the following conditions: * Fracture of angle of mandible. * Radiological evidence of cyst or tumour. * Incomplete root formation. * Acute pulpitis or severe pericoronitis that is not under-controlled. * Gross dental caries. * Retained roots of mandibular third molar with history of removal of unerupted/impacted M3. * Patient's age \<18 years old or \> 35 years old * M2 with periapical inflammation, periodontitis, distal caries or delayed or non-responsive pulp sensibility test to exclude tooth with perio-endo lesion. * Pregnant woman. * Patient on oral contraceptives. * Current or previous bisphosphonate therapy or history of radiotherapy to the jaws. * Active smoker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal health assessment on lower second molar | baseline on day of surgery, 12 weeks and 24 weeks after surgery | 1. Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health. 2. Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health. 3. Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while \>5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health. 4. Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone gain | radiograph taken prior to surgery and 24 weeks after surgery | Comparing bone gain in lower third molar socket by comparing pre operative and post operative radiograph. Measurement in milimeter. |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORChuey Chuan Tan, MClinDent (OMFS)
Universiti Malaya, Malaysia
STUDY_DIRECTORWei Cheong Ngeow, Phd
University of Malaya
Outcome results
None listed