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Guided Bone Regeneration With Particulate Versus Block Graft

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ClinicalTrials.gov Identifier: NCT03646734
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Zekeriya Tasdemir, TC Erciyes University

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.

Condition or disease
Surgery

Detailed Description:
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. 30 systemically healthy individuals with inadequate alveolar bone crest width who requested implant placement (15 Female and 15 Male) participated in this study. After an initial examination, 15 patients were assigned to GBR with block graft (GBR-BG) and 15 were assigned to GBR particulate autograft plus xenograft (GBR-AX). Bone thickness was recorded before surgery and at a post-operative 6th month. Complications as Bleeding, Hematoma, Flap dehiscence, Infection, Numbness were evaluated. Patients were requested to record pain and swelling via visual analog scale (VAS) at 3rd, 7th and 14th days after surgery. The swelling was also recorded by an experienced clinician at 3rd, 7th and 14th days after surgery. Cost, time for patient preparation, time for surgery, fatigue of the physician caused by surgery were also determined.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Guided Bone Regeneration With Particulate Versus Block Graft: Evaluation of the Two Techniques From the Point of View of the Physician and the Patient
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : April 10, 2018

Group/Cohort
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



Primary Outcome Measures :
  1. bone gain [ Time Frame: 6 month after surgery ]
    Bone gain was calculated by cone beam computerized tomography


Secondary Outcome Measures :
  1. Pain [ Time Frame: Post-operative pain was assessed at 3, 7, and 14 days. ]
    Pain was evaluated by visual analog scale Visual analog scale (VAS) consist of 10 units, in combination with a graphic rating scale. On the VAS, the left and right end of the graphic represented the absence of pain (score 0) and the most severe pain (score 10), respectively. Patients were warned to fulfill the VAS, taking into consideration the intensity of their pain in the previous 24 hours on all recall days.



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Ages Eligible for Study:   30 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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
Criteria

Inclusion Criteria:

  • 30 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.

Exclusion Criteria:

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

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): NCT03646734


Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Zekeriya Taşdemir, Phd TC Erciyes University

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Responsible Party: Zekeriya Tasdemir, Principal investigator, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03646734     History of Changes
Other Study ID Numbers: Zek
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No