NCT03646734

Brief Summary

The aim of present study was to compare two bone augmentation techniques (Guided Bone Regeneration, GBR, with autogenous block graft and GBR with particulate autograft plus xenograft) in terms of efficacy, complications, operational parameters (cost of the materials used, time for patient preparation, time for surgery, fatigue of the physician caused by surgery) tolerability by the patient and patient comfort.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 10, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 21, 2018

Last Update Submit

August 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • bone gain

    Bone gain was calculated by cone beam computerized tomography

    6 month after surgery

Secondary Outcomes (1)

  • Pain

    Post-operative pain was assessed at 3, 7, and 14 days.

Study Arms (2)

Guided Bone Regeneration with Particulate graft

patients who had inadequate alveolar crest (crest width \<4mm) and requested of dental implant placement, treated with guided bone regeration with particulate graft

Guided Bone Regeneration with block graft

patients who had inadequate alveolar crest (crest width \<4mm) and requested of dental implant placement, treated with guided bone regeration with block graft

Eligibility Criteria

Age30 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All patients admitted to the clinic with a complaint of tooth loss and inadequate alveolar crest (crest width \<4mm) and requested of dental implant placement were examined. Patients with any systemic disease , smoking or alchol habits and medications did not included into the study due to avoid any possible effects on our results

You may qualify if:

  • to 62 years of age
  • systemically health
  • no smoking
  • no use of medications for previous 6 months
  • no pregnancy and lactation
  • no contraindications for periodontal surgery.

You may not qualify if:

  • \<30 and \>62 years of age
  • patients with systemic disease
  • smoking habit ( current or past)
  • any medication
  • acute illness
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Zekeriya Taşdemir, Phd

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 24, 2018

Study Start

January 10, 2017

Primary Completion

January 10, 2018

Study Completion

April 10, 2018

Last Updated

August 24, 2018

Record last verified: 2018-08