Clinical trial NCT03646734: Guided Bone Regeneration With Particulate Versus Block Graft
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: bone gain
timeFrame: 6 month after surgery
Secondary outcomes:
measure: Pain
timeFrame: Post-operative pain was assessed at 3, 7, and 14 days.
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Zekeriya Taşdemir, Phd
role: PRINCIPAL_INVESTIGATOR
References: