UnknownPhase 2/3

COMPARATIVE ANALYSIS OF INNOVATIVE BONE HEALING TECHNIQUES

Pakistan60 participantsStarted 2020-12-17

Plain-language summary

the study intends to observe the outcome of interventions (concentrated growth factor with autograft and xenograft) used to expedite bone healing and adaptation with minimal side effects. Three different modalities are being used to bridge the mandibular fracture defects (\>5mm-\<5cm). Those modalities include group A- autograft, group B-autograft with concentrated growth factor, and group C- xenograft with concentrated growth factor. the outcomes are measured in terms of acquired bone density (Hounsfield unit) that is obtained at the 4th and 6th month post-operatively via cone-beam computed tomography.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male/female * Mandible fracture (symphysis, parasymphysis, and body) * Defect gap of bone \>5mm and \<5cm. * Non-union fracture. (Fracture that does not heal after 8 weeks of treatment is known as a non-union) * Mal-union (when the fracture segments are not in anatomical alignment and heals in that way forming a bone between displaced segments) * Delayed union (Fracture which takes greater than 5 weeks to repair is a delayed union) Exclusion Criteria: * Systemic disease involvement such as diabetes mellitus. * Bone-related disorders such as osteoarthritis, * Undergoing Chemo and or radiotherapy * Gunshot trauma with more than 5cm bone defect * Fracture with open wounds

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

bone density

Timeframe: 6 months

Trial details

NCT IDNCT05480631

SponsorDow University of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-20

View on ClinicalTrials.gov More To Assess the Bone Healing in Fracture Mandible Defects trials