Immediate Implant With Bone GraftNCT02613663
Immediate Implant Using "Nanobone" Versus "Autogenous Bone" for Treatment of Patients With Unrestorable Single Tooth.
A study testing Immediate implants with nanobone graft and immediate implants with autogenous bone graft in people with Immediate Implant With Bone Graft, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant With Bone Graft
- What is being tested?
- Immediate implants with nanobone graft and immediate implants with autogenous bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine. Cairo University
Giza, Cairo Governorate, 11553
About this study
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.
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.
Read the 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.
- Conditions
- Immediate Implant With Bone Graft
- Being tested
- Immediate implants with nanobone graft, immediate implants with autogenous bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implants with nanobone graftProcedure or surgery
Also called Nano-hydroxy apatite bone graft with immediate implants
Extraction of unrestorable tooth replaced with immediate implant and use nanobone graft to fill the gap.
immediate implants with autogenous bone graftProcedure or surgery
Also called autograft used with immediate implants.
Extraction of unrestorable tooth replaced with immediate implant and use autogenous bone graft to fill the gap.
| Study group | Role | What they receive |
|---|---|---|
| immediate implants with nanobone graft | Experimental | Nano-hydroxyapatite bone graft fill the gap between immediate implant and labial bone wall. Receives: Procedure: Immediate implants with nanobone graft |
| immediate implants with autogenous bone graft | Active comparator | Autogenous graft fill the gap between immediate implant and labial bone wall. Receives: Procedure: immediate implants with autogenous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
device for measurement is stop watch, unit of measurement is minutes.
Measured: during surgery
post-operative pain
device for measurement is visual analog scale, unit of measurement is 1-10 scale.
Measured: during 3 days after surgery
Secondary outcomes (2)
degree of implant stability
device of measurement is periotest, unit of measurement discrete number.
Measured: after 6 month from the surgery
Marginal bone loss
device of measurement is digital radiograph, unit of measurement millimeter.
Measured: after 6 month from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJul 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immediate Implant With Bone GraftStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ahmed Nouby Adam, Cairo University
- Investigators
- Samar Nouby, Principal investigator, Oral and dental medicine faculty, Cairo university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613663
- Sponsor's protocol ID
- SAdam
- Status last verified
- May 2018
- First submitted
- 17 Nov 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 15635948Becker 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.
PubMed 8820122Costantino PD, Friedman CD. Synthetic bone graft substitutes. Otolaryngol Clin North Am. 1994 Oct;27(5):1037-74.
PubMed 7816433Nemeth 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.
PubMed 12577407
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02613663
- Acronym / sponsor ID
- SAdam
- Conditions
- Immediate Implant With Bone Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implants with nanobone graft | Experimental | Procedure: Immediate implants with nanobone graftNano-hydroxyapatite bone graft fill the gap between immediate implant and labial bone wall. |
| immediate implants with autogenous bone graft | Active comparator | Procedure: immediate implants with autogenous bone graftAutogenous graft fill the gap between immediate implant and labial bone wall. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implants with nanobone graftAlso: Nano-hydroxy apatite bone graft with immediate implantsExtraction of unrestorable tooth replaced with immediate implant and use nanobone graft to fill the gap. | Procedure or surgery | immediate implants with nanobone graft |
| immediate implants with autogenous bone graftAlso: autograft used with immediate implants.Extraction of unrestorable tooth replaced with immediate implant and use autogenous bone graft to fill the gap. | Procedure or surgery | immediate implants with autogenous bone graft |
Primary outcome
Surgical time
Time frame: during surgery
device for measurement is stop watch, unit of measurement is minutes.
post-operative pain
Time frame: during 3 days after surgery
device for measurement is visual analog scale, unit of measurement is 1-10 scale.
2 secondary outcomes
degree of implant stability
Time frame: after 6 month from the surgery
Marginal bone loss
Time frame: after 6 month from the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Results publication: PubMed 15635948Chiapasco M. Early and immediate restoration and loading of implants in completely edentulous patients. Int J Oral Maxillofac Implants. 2004;19 Suppl:76-91.
- Results publication: PubMed 8820122Becker 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.
- Results publication: PubMed 7816433Costantino PD, Friedman CD. Synthetic bone graft substitutes. Otolaryngol Clin North Am. 1994 Oct;27(5):1037-74.
- Results publication: PubMed 12577407Nemeth 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.
- Rationale for the application of immediate load in implant dentistry: Part I. Implant DentistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar Nouby principal investigator
Oral and dental medicine faculty, Cairo university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implants with nanobone graft and immediate implants with autogenous bone graft in people with Immediate Implant With Bone Graft, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical time (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02613663, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.