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Immediate Implant Using Nanobone Versus Autogenous Bone for Treatment of Patients With Unrestorable Single Tooth.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02613663
Enrollment
18
Registered
2015-11-24
Start date
2016-07-31
Completion date
2018-05-31
Last updated
2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant With Bone Graft

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.

Interventions

PROCEDUREImmediate implants with nanobone graft

Extraction of unrestorable tooth replaced with immediate implant and use nanobone graft to fill the gap.

PROCEDUREimmediate implants with autogenous bone graft

Extraction of unrestorable tooth replaced with immediate implant and use autogenous bone graft to fill the gap.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Surgical timeduring surgerydevice for measurement is stop watch, unit of measurement is minutes.
post-operative painduring 3 days after surgerydevice for measurement is visual analog scale, unit of measurement is 1-10 scale.

Secondary

MeasureTime frameDescription
degree of implant stabilityafter 6 month from the surgerydevice of measurement is periotest, unit of measurement discrete number.
Marginal bone lossafter 6 month from the surgerydevice of measurement is digital radiograph, unit of measurement millimeter.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026