Guided Bone Regeneration With Particulate Versus Block Graft

Guided Bone Regeneration With Particulate Versus Block Graft: Evaluation of the Two Techniques From the Point of View of the Physician and the Patient

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone gain	Bone gain was calculated by cone beam computerized tomography	6 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	Post-operative pain was assessed at 3, 7, and 14 days.

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Zek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No