Comparing the bone regrowth with and without the use of 3D scaffold material after lower molar tooth removal

Comparative evaluation of the bone regeneration with and without use of 3d scaffold matrix in adult patients in defects following intra-alveolar extraction of mandibular molars – An Observer Blind Prospective Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068115

Enrollment

Registered

2024-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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: Use of 3D scaffold matrix: Immediately after the extraction, for participant from Group A nano hydroxyapatite scaffold will be placed in the extraction socket and evaluate quality and

Eligibility

Inclusion criteria

Inclusion criteria: a) Participants undergoing dental extraction of Mandibular 1st or 2nd molars. b) Participants within age group from 18-60 years of either gender. c) Participants willing to be followed up for 12 weeks. d) Participants willing to undergo Dental Implant placement following extraction of the Mandibular Molar at 12 weeks post extraction.

Exclusion criteria

Exclusion criteria: a) Participants demonstrating periapical infection/ osteomyelitis/ tissue space infection in association with the Mandibular molar indicated for extraction. b) Teeth which require trans-alveolar method of extraction under local anaesthesia c) Lone standing Mandibular first or second molars indicated for extraction. d) Patients suffering from systemic disease like diabetes mellitus, osteoporosis, auto immune diseases and on Medications which are proven to affect bony wound healing. e) Female patients who are pregnant. f) Participants indicated for Mandibular third molar extractions.

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the defect fill and alveolar crest resorption along with height and width of the residual alveolar ridge at the site of extraction of mandibular molars by means of CBCT following extraction in adult participants with and without the use of 3D scaffold matrixTimepoint: Baseline and 12 weeks	—

Secondary

Measure	Time frame
Primary objective 2- To evaluate & compare the bony regenerate in the extraction socket at 12 weeks for Bone mineral density (BMD), Bone tissue volume/ total tissue volume (BTV/TV), Trabecular thickness (Tb.Th), & trabecular separation/spacing (Tb.sp) through High resolution Micro CT in adult participants with & without the use of 3D scaffold matrix.Timepoint: At 12 weeks;Primary objective 3- To evaluate & compare the Histomorphometry of the bony regenerate in the extraction socket at 12 weeks post extraction for presence or absence of Woven bone, Lamellar bone, Nonviable bone, Residual scaffold material & Connective tissue in adult participants with & without the use of 3D scaffold matrix.Timepoint: At 12 weeks;To evaluate and compare the socket wound healing at 3 days and 7 days following extraction with and without use of 3D Scaffold Matrix in adult participants in defects following intra-alveolar extraction of Mandibular Molars.Timepoint: Day 3 and day 7 post extraction	—

Measure

Time frame

Primary objective 2- To evaluate & compare the bony regenerate in the extraction socket at 12 weeks for Bone mineral density (BMD), Bone tissue volume/ total tissue volume (BTV/TV), Trabecular thickness (Tb.Th), & trabecular separation/spacing (Tb.sp) through High resolution Micro CT in adult participants with & without the use of 3D scaffold matrix.Timepoint: At 12 weeks;Primary objective 3- To evaluate & compare the Histomorphometry of the bony regenerate in the extraction socket at 12 weeks post extraction for presence or absence of Woven bone, Lamellar bone, Nonviable bone, Residual scaffold material & Connective tissue in adult participants with & without the use of 3D scaffold matrix.Timepoint: At 12 weeks;To evaluate and compare the socket wound healing at 3 days and 7 days following extraction with and without use of 3D Scaffold Matrix in adult participants in defects following intra-alveolar extraction of Mandibular Molars.Timepoint: Day 3 and day 7 post extraction

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Countries

India

Contacts

Public ContactSrivalli Natarajan

MGM Dental College and Hospital Kamothe

srivalli.shrikanth@gmail.com9769088803

Outcome results

None listed

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