Teriparatide for mandibular fracture healing

Evaluation of Teriparatide as a promoter of mandibular fracture healing - An observational clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044443

Enrollment

Registered

2022-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: M268- Other dentofacial anomalies

Interventions

Intervention1: Teriparatide for mandibular fracture healing: Study group - Teriparatide Dosage - 28.2 mcg Route of administration - Subcutaneous Frequency - Twice a week Duration - 4 weeks Total numbe

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 - 70 years. 2) Patients with mandibular fractures (condyle, angle, ramus, body, symphysis, parasymphysis) 3) Patients categorised as ASA II status, because of alcohol consumption & smoking (October 15,2014 regulation)

Exclusion criteria

Exclusion criteria: 1) Patients with fractures pertaining to regions other than the mandible 2) Presence of bone pathology 3) Patients with thyroid dysfunction 4) Individuals categorised under ASA I, III or IV. 5) Patients belonging to category II because of reasons other than smoking & alcoholism

Design outcomes

Primary

Measure	Time frame
1) Pain by clinical evaluation using Numerical pain Rating Scale 2) Bone mineral density by CT imaging 3) Bone formation by biochemical evaluation of serum osteocalcin 4)Bone mineralisation by biochemical evaluation of serum P1NPTimepoint: 1) Pain by clinical evaluation using Numerical pain Rating Scale - first to seventh post-op days, fourteenth and twenty first post-op day 2) Bone mineral density by CT imaging - Preoperative and sixth post operative week 3) Bone formation by biochemical evaluation of serum osteocalcin - Preoperative and thirtieth postoperative day 4)Bone mineralisation by biochemical evaluation of serum P1NP - Preoperative and thirtieth post operative day	—

Measure

Time frame

1) Pain by clinical evaluation using Numerical pain Rating Scale 2) Bone mineral density by CT imaging 3) Bone formation by biochemical evaluation of serum osteocalcin 4)Bone mineralisation by biochemical evaluation of serum P1NPTimepoint: 1) Pain by clinical evaluation using Numerical pain Rating Scale - first to seventh post-op days, fourteenth and twenty first post-op day 2) Bone mineral density by CT imaging - Preoperative and sixth post operative week 3) Bone formation by biochemical evaluation of serum osteocalcin - Preoperative and thirtieth postoperative day 4)Bone mineralisation by biochemical evaluation of serum P1NP - Preoperative and thirtieth post operative day

—

Secondary

Measure	Time frame
Interfragmentary mobilityTimepoint: Immediate post-operative, 7th postoperative day, 14th post-operative day, 4th post-operative week, 6th post-operative week;Post-operative analgesics requirementTimepoint: Third to seventh postoperative day;Mouth openingTimepoint: Immediate post-operative, 7th postoperative day, 14th post-operative day, 4th post-operative week, 6th postoperative week	—

Countries

India

Contacts

Public ContactDrElavenilP

SRM Dental College, Ramapuram

elavenilomfs@gmail.com9841254653

Outcome results

None listed

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