NCT02613663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

November 17, 2015

Last Update Submit

May 11, 2018

Conditions

Immediate Implant With Bone Graft

Outcome Measures

Primary Outcomes (2)

  • Surgical time

    device for measurement is stop watch, unit of measurement is minutes.

    during surgery

  • post-operative pain

    device for measurement is visual analog scale, unit of measurement is 1-10 scale.

    during 3 days after surgery

Secondary Outcomes (2)

  • degree of implant stability

    after 6 month from the surgery

  • Marginal bone loss

    after 6 month from the surgery

Study Arms (2)

immediate implants with nanobone graft

EXPERIMENTAL

Nano-hydroxyapatite bone graft fill the gap between immediate implant and labial bone wall.

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.

Procedure: immediate implants with autogenous bone graft

Interventions

Immediate implants with nanobone graftPROCEDURE

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

Also known as: Nano-hydroxy apatite bone graft with immediate implants
immediate implants with nanobone graft
immediate implants with autogenous bone graftPROCEDURE

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

Also known as: autograft used with immediate implants.
immediate implants with autogenous bone graft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine. Cairo University

Giza, Cairo Governorate, 11553, Egypt

Location

Related Publications (4)

  • Chiapasco M. Early and immediate restoration and loading of implants in completely edentulous patients. Int J Oral Maxillofac Implants. 2004;19 Suppl:76-91.

    PMID: 15635948RESULT

  • 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.

    PMID: 8820122RESULT

  • Costantino PD, Friedman CD. Synthetic bone graft substitutes. Otolaryngol Clin North Am. 1994 Oct;27(5):1037-74.

    PMID: 7816433RESULT

  • 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.

    PMID: 12577407RESULT

Related Links

Study Officials

  • Samar Nouby

    Oral and dental medicine faculty, Cairo university.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Samar Ahmed Nouby Adam

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 24, 2015

Study Start

July 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)