Alveolar Bone Resorption
Conditions
Brief summary
The present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure.
Detailed description
* After local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest. * Tooth extraction will be performed using atraumatic extraction methods using Periotome. * After extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution. * The socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group. * Intra surgical measurements will be recorded. * Socket preservation will be performed with either Demineralized dentin matrix DDM(TEST) or bovine derived xenograft DBM (CONTROL). Bone graft will be extended to the height of intra proximal bone. * Collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest. * Flaps will be approximated with sutures.
Interventions
PROCEDUREsocket preservation
Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)
Sponsors
Krishnadevaraya College of Dental Sciences & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Teeth indicated for extraction and subsequent implant placement * Age group of 18 to 55 years * Single rooted tooth indicated for extraction due to endodontic failure, caries or Fracture * Presence of \>2 mm keratinized tissue to allow flap management * Extraction site should have adjacent tooth on either side * Systemically healthy patients * Class II or III extraction socket defects according to Hammerele and Jung(2008) * Full mouth plaque score(FMPS)\<25% at baseline.(PI) * Full mouth bleeding score(FMBS)\<25% at baseline. (BI)
Exclusion criteria
* .Presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls * Medical conditions contraindicating surgical interventions * Known smokers and alcoholics * Subjects with known bone metabolic disorders.(Pagets disease,fibrous dysplasia etc.) * Acute infections at the site of extraction. Eg , Abscess * History of malignancy * Patients who have undergone radiotherapy or chemotherapy * Periapical pathology such as granulomas, cyst, hypercementosis, ankylosis. * Pregnant and lactating women * Maxillary and mandibular 3rd molars.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height of Alveolar Crest and Bucco-Lingual Ridge Width | 6 Months | Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm |
| Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG) | 6 MONTHS | CBCT (Cone Beam Computer Tomography) measured in mm |
| New Bone Formation % and Residual Bone Graft | 6 MONTHS | HISTOMORPHOMETRIC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 6months | Silness and Leo index using UNC-15 PROBE with Rating Score Excellent- 0 Good- 0.1 - 0.9 Fair -1.0 - 1.9 Poor - 2.0 - 3.0 |
| Bleeding Index | 6 months | Mombelli - Sulcus Bleeding Index using UNC-15 Probe with Rating Score 0- No bleeding 1 -Isolated bleeding spots visible 2-Blood forms a confluent red line on the margin 3- Heavy or profuse bleeding |
| Patient Reported Outcome Measures for Pain and Esthetics | 6 months | ( Visual Analog Scale -VAS) Rating score, None (0) Mild (1-3) Moderate (4-6) Severe (7-10) |
Countries
India
Contacts
Primary ContactDr.JOANN PAULINE GEORGE, MDS
Backup ContactDr.SALMA BANU C, MDS
Outcome results
None listed