Guided Bone Regeneration With Particulate Versus Block Graft

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646734
• Other study ID #: Zek
• Status: Completed
• Start date: January 10, 2017
• Est. completion date: April 10, 2018

Study information

• Verified date: August 2018
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone gain	Bone gain was calculated by cone beam computerized tomography	6 month after surgery
Secondary	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.