Guided Bone Regeneration With Particula… | Clinical Trial

Key information

Conditions

Surgery

Age range

30 year–62 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

bone gain

Time frame: 6 month after surgery

Bone gain was calculated by cone beam computerized tomography

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 24, 2018
Registry last updated: Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed