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Pilot clinical investigation of alveolar ridge augmentation using 3-D scaffold matrix

Phase 1
Completed
Conditions
Health Condition 1: M267- Dental alveolar anomalies
Registration Number
CTRI/2019/10/021532
Lead Sponsor
Indian Institute of Technology Bombay
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

a)Male and female patients with age group from 18-55 years

b)Patients which are up for extraction sockets

c)Patient is willing to be followed for 6 months

d)Participants tested negative on skin test for hypersensitivity to Carboxymethyl chitin.

Exclusion Criteria

a)Cases of infection and osteomyelitis occurring from trauma, accident, and facial inju-ry.

b)Patients suffering from disease like diabetes mellitus, hyperthyroid, systemic diseases.

c)Patients suffering from infectious disease and cardiovascular disease.

d)Smokers and patients with history of auto-immune diseases, osteoporosis.

e)Patients with adverse medical history will be excluded.

f)Female patients who are pregnant.

g)Participants tested positive on skin test for hypersensitivity to Carboxymethyl chitin.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To study the safety, tolerability and efficacy of 3-D Scaffold Matrix (bone graft) for dental bone defectTimepoint: There are five timepoints <br/ ><br>1. Baseline <br/ ><br>2. One week <br/ ><br>3. One month <br/ ><br>4. Three month <br/ ><br>5. Six month
Secondary Outcome Measures
NameTimeMethod
To study the quality of boneTimepoint: There are two timepoints <br/ ><br>1. Baseline <br/ ><br>2. Six month <br/ ><br>3. twelve month
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