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

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ClinicalTrials.gov Identifier: NCT02613663
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Samar Ahmed Nouby Adam, Cairo University

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.

Condition or disease Intervention/treatment Phase
Immediate Implant With Bone Graft Procedure: Immediate implants with nanobone graft Procedure: immediate implants with autogenous bone graft Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: immediate implants with nanobone graft
Nano-hydroxyapatite bone graft fill the gap between immediate implant and labial bone wall.
Procedure: Immediate implants with nanobone graft
Extraction of unrestorable tooth replaced with immediate implant and use nanobone graft to fill the gap.
Other Name: Nano-hydroxy apatite bone graft with immediate implants

Active Comparator: immediate implants with autogenous bone graft
Autogenous graft fill the gap between immediate implant and labial bone wall.
Procedure: immediate implants with autogenous bone graft
Extraction of unrestorable tooth replaced with immediate implant and use autogenous bone graft to fill the gap.
Other Name: autograft used with immediate implants.




Primary Outcome Measures :
  1. Surgical time [ Time Frame: during surgery ]
    device for measurement is stop watch, unit of measurement is minutes.

  2. post-operative pain [ Time Frame: during 3 days after surgery ]
    device for measurement is visual analog scale, unit of measurement is 1-10 scale.


Secondary Outcome Measures :
  1. degree of implant stability [ Time Frame: after 6 month from the surgery ]
    device of measurement is periotest, unit of measurement discrete number.

  2. Marginal bone loss [ Time Frame: after 6 month from the surgery ]
    device of measurement is digital radiograph, unit of measurement millimeter.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613663


Locations
Egypt
Faculty of Oral and Dental Medicine. Cairo University
Giza, Cairo, Egypt, 11553
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Samar Nouby Oral and dental medicine faculty, Cairo university.