A clinical trial to study the effects of ICB Bone Grafts in Oral Maxillofacial Surgery Applications.

Post-Market phase IV Clinical Study to Determine Safety & Performance and Efficacy of ICB Bone Allografts in Oral Maxillofacial Surgery Applications in Indian Population presenting with Need to Correct, Restructure, Fill/Support, Rebuild, Repair and/or Replace Bone Due to Bony Defects or Deficiencies or Bone Loss. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/03/023671

Enrollment

230

Registered

2020-03-02

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: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: ICB Bone Grafts: The ICB bone allografts involves procuring recovered musculoskeletal human donor tissue from US FDA compliant and accredited recovery (procurement) banks

the procurement and selection of the donors meets the regulatory requirements for human donor tissue, current Good Tissue Practices (cGTP) The products are: - ICBâ?¢ BoneBlock (BB) cancellous/cortica

Eligibility

Inclusion criteria

Inclusion criteria: Presents with serious bone deficiency or defects in oral maxillofacial area which requires correction using ICB bone allograft material.

Exclusion criteria

Exclusion criteria: Medically compromised patients are excluded from the trial but only after screening. The final determination of exclusion will be left to the discretion of investigator, an experienced oral maxillofacial surgeon; there is no consultation with the monitor or the sponsor.

Design outcomes

Primary

Measure	Time frame
The primary study objective for this Phase IV trial is to evaluate and determine the safety & performance including remodelling of ICB Bone Allografts in oral maxillofacial surgery applicationsTimepoint: 14 days, 30 days, 90 days and 180 days	—

Secondary

Measure	Time frame
The secondary study objective of this Post-market trial is to evaluate efficacy (effectiveness) of the bone grafting in maxillofacial surgery using ICB Bone Allografts. Efficacy assessment may include wound care, remodelling through dental imaging and mean healing time.Timepoint: At the end of 6 months	—

Countries

India

Contacts

Public ContactS Jayaraman

Lakshmi Associates

lassociates2004@yahoo.co.in919790914529

Outcome results

None listed

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