Increasing the width of residual jaw bone using a combination of ones own bone and bone substitute with screw placement at the same time

Recruiting

• Conditions: Patients with atrophic edentulous maxilla and mandible willing for Implant supported prosthesis

• Registration Number: CTRI/2018/04/013497
• Lead Sponsor: Dr Tarun Kumar AB

Brief Summary

Endosseous implants have gained wide acceptance as treatment of choice for replacement of missing teeth. An important requisite for success of implant is osseointegration which requires adequate quality and quantity of bone. An insufficient amount of alveolar ridge in both dimensions, vertical and horizontal is often encountered in dental practice due to the consequences of oral diseases and tooth loss. This has led to the development of several methods for alveolar ridge augmentation. Augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone

support for osseointegrated dental implants.

This study is conducted for a duration of 6 months to evaluate

1.     the effectiveness of combination of autogenous particulated bone graft and

ABBM and its stabilization using native collagen membrane in augmenting horizontal

ridge defects and

2.  To evaluate pre and post-operative changes in ridge width and to quantify the gain in

ridge width along with osseointegration of implants, 6 months post treatment using clinical

and radiographic assessment

 A total of 12 patients are selected from the out-patient department of Periodontics, Bapuji Dental College and Hospital based on the inclusion criteria. Informed consent was obtained and after complete blood investigation and assessment of pre-operative CBCT scan, patient was scheduled for the procedure.

 Under local anesthesia, implants of ideal diameter are placed within the prepared osteotomy site, the implant exposure and the horizontal defect is augmented with a mixture of autogenous bone and Anorganic bovine bone mineral. A resorbable membrane is secured over the gtaft using titanium tacks and periosteal vertical mattress suture followed by tension free flap closure of the surgical site.

Following clinical parameters are recorded:

• Primary implant stability will be measured using insertion torque value and

Implant Stability quotient (ISQ) by resonance frequency analysis

• Length of implant exposure is measured in millimeter (mm) using colorvue

UNC12 probe at baseline and 6 months post-operatively to check for wound

dehiscence

• Clinical measurement of ridge width will be carried using a caliper at baseline and

six months of augmentation procedure to quantify the difference in ridge width

 Radiographic analysis is done on the sagittal section of CBCT scan. Appropriate statistical analysis will be done.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male and female subjects within the age group of 18-45 years 2.
• Subjects with good general health 3.
• Subjects with good oral hygiene 4.
• Horizontal ridge defect with bucco-lingual dimension of > 2mm to ≤ 5 mm at crest 5.
• Edentulous ridges with one to four teeth missing 6.
• Horizontal ridge deficiency at the level of alveolar crest 7.
• Site with small to moderate bone defect 8.
• Site should allow implant insertion with primary stability and optimal prosthetic positioning.

Exclusion Criteria

• Subjects with compromised medical history that would complicate the outcome of the study 2.
• Subjects who are smokers, alcoholics and tobacco chewers 3.
• Women who are pregnant or lactating mothers 4.
• Subjects with high or moderate parafunctional activity 6.
• Subjects on drug therapy which can affect the outcome of the treatment (Bisphosphonates, anti-platelets and anti-coagulants) 7.
• Subjects with vertical ridge defects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The gain in ridge width which is the difference between the post-operative and pre-operative bone width	The gain in ridge width which is the difference between the post-operative and pre-operative bone width

Secondary Outcome Measures

Name	Time	Method
Implant stability Quotient (ISQ). ISQ uses resonance frequency analysis	Implant stability will be measured at the time of implant placement and 6 months post-operatively

Trial Locations

Locations (1)

Bapuji Dental College and Hospital; 🇮🇳 Davanagere, KARNATAKA, India

Bapuji Dental College and Hospital

🇮🇳Davanagere, KARNATAKA, India

Dr Tarun Kumar AB

Principal investigator

9886210507

tarundental@gmail.com