Clinical trial NCT02613663: Immediate Implant Using "Nanobone" Versus "Autogenous Bone" for Treatment of Patients With Unrestorable Single Tooth.
Official title: Evaluation of Surgical Time, Post-operative Pain and Marginal Bone Loss in Immediate Implant Using "Nanobone" Versus "Autogenous Bone" for Treatment of Patients With Unrestorable Single Tooth: Randomized Controlled Trials.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implant With Bone Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A successful implant therapy require appropriate hard and soft tissue, perfect implant position, appropriate alveolar ridge architecture and integration of the implant. after tooth extraction bone resorption takes place and affect the quantity and quality of the bone resulting in inadequate bone volume for implant placement and future prosthetic restoration and impair the esthetic, so insertion of implant immediately following tooth extraction reduce bone loss and enhance esthetics.the fresh socket of extracted tooth is wider than the implant diameter and the distance between the implant and the bone called Peri-implant gap which influence the stability, osseointegration of the implants and esthetics. using bone graft in this gap between bone and implant enhance osseointegration and post-operative healing. autogenous bone graft considered the gold standard graft material for filling defects as it is osteogenic,osseoconductive and osseoinductive, however this approach obtained from the primary donor site for harvesting bone in the oral cavity which requires longer surgical procedure and produce not enough bone volume. there are several post-operative complication may happen as donor site morbidity and swelling,discomfort and pain, so alternative treatment has been suggested using biomaterials to fill the gap and reduce adverse effect of autogenous grafts.Several studies evaluate the success rate of implants with "autogenous" bone graft versus other synthetic guided bone regeneration materials. Nano porous grafting material as a new synthetic material "nanobone" nanocrystalline hydroxyapatite embedded in a porous silica gel matrix has oseoconductive and biomimetic properties integrate with the host bone. the sub-micron modification in bone substitutes enhance osteogenic property. the objective of this study is to measure surgical time, pain, implant stability and marginal bone loss in immediate implant placement with using autogenous bone graft versus nanobone graft.

Detailed description: Immediate implant placement with Nanobone will offers great advantages for patients with unrestorable tooth as regards decrease surgical time, Post-Operative pain and marginal bone loss, increase implant stability compared to immediate implant with autogenous bone graft.Study is to be conducted in the oral medicine and periodontology department - Cairo University, Egypt. Post graduate clinic 1st floor old section. Unit Sirona2with LED light. Digital radiographic imaging will be carried out in the Oral Radiology Department, Faculty of Oral and Dental Medicine, Cairo University using digital intra-oral x-ray machine as well as CBCT imaging. Using CBCT determine the size and length of fixture will be used. After a traumatic extraction, using drills to prepare the socket for the implant. Standard drilling procedures are performed according to the manufacturer's instructions implant direct. The axis of the implant must correspond to the incisal edges of the adjacent teeth or be slightly palatal to this landmark. Place the exact size determined previously by CBCT. In the esthetic zone, the implant head should be a minimum of 3 mm apical to an imaginary line connecting the cemento-enamel junctions of the adjacent teeth and apical to the interproximal and crestal bone.The gap between the facial aspect of the implant and the buccal wall was filled with NanoBone.The flap will be scored and sutured in place without tension. While in the control group, Harvesting of the autogenous bone graft will be done. This group will be subjected to the same implant placement protocol as the study group. Postoperative care include; A dressing will be applied to the extraoral wound for 24 hours postoperatively in the control group, Patients will maintain on oral antibiotics (Amoxicillin/Clavulanic acid 1gm q12h) and analgesics (cataflam 50 mg q8h) for 5 more days. Chlorohexidine mouth wash will be prescribed for 2 more weeks.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from unrestorable tooth that candidate for classical implant placement .
* Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
* Good oral hygiene and teeth bounding the alveolar ridge is not periodontally affected.

Exclusion Criteria:

* Patients with any systemic disease that may affect normal healing.
* Patient with bad oral hygiene.
* Intra oral soft tissue defect that would affect the closure of the intra oral wound.
* Patients with severely atrophic ridges requiring a staged grafting procedure.

Primary outcomes:
measure: Surgical time
timeFrame: during surgery
measure: post-operative pain
timeFrame: during 3 days after surgery
Secondary outcomes:
measure: degree of implant stability
timeFrame: after 6 month from the surgery
measure: Marginal bone loss
timeFrame: after 6 month from the surgery
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Oral and Dental Medicine. Cairo University
state: Cairo
Study officials:
affiliation: Oral and dental medicine faculty, Cairo university.
name: Samar Nouby
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiapasco M. Early and immediate restoration and loading of implants in completely edentulous patients. Int J Oral Maxillofac Implants. 2004;19 Suppl:76-91.
citation: Becker W, Becker BE. Flap designs for minimization of recession adjacent to maxillary anterior implant sites: a clinical study. Int J Oral Maxillofac Implants. 1996 Jan-Feb;11(1):46-54.
citation: Costantino PD, Friedman CD. Synthetic bone graft substitutes. Otolaryngol Clin North Am. 1994 Oct;27(5):1037-74.
citation: Nemeth Z, Suba Z, Hrabak K, Barabas J, Szabo G. [Autogenous bone versus beta-tricalcium phosphate graft alone for bilateral sinus elevations (2-3D CT, histologic and histomorphometric evaluations)]. Orv Hetil. 2002 Jun 23;143(25):1533-8. Hungarian.