- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613663
Immediate Implant Using "Nanobone" Versus "Autogenous Bone" for Treatment of Patients With Unrestorable Single Tooth.
May 11, 2018 updated by: Samar Ahmed Nouby Adam, Cairo University
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.
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Cairo
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Giza, Cairo, Egypt, 11553
- Faculty of Oral and Dental Medicine. Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: immediate implants with nanobone graft
Nano-hydroxyapatite bone graft fill the gap between immediate implant and labial bone wall.
|
Extraction of unrestorable tooth replaced with immediate implant and use nanobone graft to fill the gap.
Other Names:
|
Active Comparator: immediate implants with autogenous bone graft
Autogenous graft fill the gap between immediate implant and labial bone wall.
|
Extraction of unrestorable tooth replaced with immediate implant and use autogenous bone graft to fill the gap.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical time
Time Frame: during surgery
|
device for measurement is stop watch, unit of measurement is minutes.
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during surgery
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post-operative pain
Time Frame: during 3 days after surgery
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device for measurement is visual analog scale, unit of measurement is 1-10 scale.
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during 3 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
degree of implant stability
Time Frame: after 6 month from the surgery
|
device of measurement is periotest, unit of measurement discrete number.
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after 6 month from the surgery
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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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after 6 month from the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samar Nouby, Oral and dental medicine faculty, Cairo university.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chiapasco M. Early and immediate restoration and loading of implants in completely edentulous patients. Int J Oral Maxillofac Implants. 2004;19 Suppl:76-91.
- 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.
- Costantino PD, Friedman CD. Synthetic bone graft substitutes. Otolaryngol Clin North Am. 1994 Oct;27(5):1037-74.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
November 17, 2015
First Submitted That Met QC Criteria
November 23, 2015
First Posted (Estimate)
November 24, 2015
Study Record Updates
Last Update Posted (Actual)
May 16, 2018
Last Update Submitted That Met QC Criteria
May 11, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- SAdam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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