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

A SINGLE CENTER, OPEN-LABEL, RANDOMISED, COMPARATIVE PILOT STUDY TO EVALUATE SAFETY, TOLERABILITY AND EFFICACY OF 3-D SCAFFOLD MATRIX (BONE GRAFT) FOR DENTAL BONE DEFECT

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021532

Enrollment

Registered

2019-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M267- Dental alveolar anomalies

Interventions

Intervention1: Ridge augmentation: It is well known that maxillofacial surgeons preserve the maximum amount of underline jaw-bone whenever a tooth is extracted. Despite this, significant degradation o

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To study the safety, tolerability and efficacy of 3-D Scaffold Matrix (bone graft) for dental bone defectTimepoint: There are five timepoints 1. Baseline 2. One week 3. One month 4. Three month 5. Six month	—

Secondary

Measure	Time frame
To study the quality of boneTimepoint: There are two timepoints 1. Baseline 2. Six month 3. twelve month	—

Countries

India

Contacts

Public ContactProf Jayesh Bellare

CDER All India Institute of Medical Sciences

ajoyroy@hotmail.com01126588500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026