Guided Bone Regeneration With Particulate Versus Block Graft

Completed

• Conditions: Surgery

• Registration Number: NCT03646734
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01-10
• Primary Completion: 2018-01-10
• Study Completion: 2018-04-10
• Status Verified: 2018-08
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone gain	6 month after surgery	Bone gain was calculated by cone beam computerized tomography

Secondary Outcome Measures

Name	Time	Method
Pain	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.