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Recruiting NCT07779421

NCT07779421 THBC/CGF for Alveolar Bone Regeneration: A Real-World Study

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Clinical Trial Summary
NCT ID NCT07779421
Status Recruiting
Phase —
Sponsor Stomatological Hospital Affiliated with Fujian Medical University
Condition Alveolar Bone Loss
Study Type INTERVENTIONAL
Enrollment 136 participants
Start Date 2024-08-01
Primary Completion 2027-05-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 60 Years
Study Type INTERVENTIONAL
Interventions
Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factorTemperature-sensitive hydroxybutyl chitosanAutologous Concentrated Growth Factor

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 136 participants in total. It began in 2024-08-01 with a primary completion date of 2027-05-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study aims to combine real-world research with relevant bone repair materials and techniques to improve alveolar bone resorption in extraction sockets following impacted wisdom tooth removal, while achieving effective bone preservation or promoting bone regeneration. All eligible cases within specified parameters will be included in the clinical study scope. Based on real-world clinical data, we will proactively collect postoperative clinical examination findings and imaging data. Statistical analysis will be performed on clinical outcomes and follow-up data from patients undergoing mandibular impacted M3 extraction. The study aims to clarify the therapeutic efficacy of the thermosensitive hydroxyethylchitosan-loaded concentrated growth factor group in repairing mesial bone defects of M2s following M3 extraction.

Eligibility Criteria

* Inclusion Criteria: * Preoperative CBCT imaging confirming mandibular third molars (M3s) with low to moderate impaction according to the Pell and Gregory classification, and not in the acute inflammatory stage. * Ipsilateral mandibular second molars (M2s) with retention value and no indication for extraction. * Patients able to provide written informed consent and willing to comply with the scheduled follow-up visits. * Age between 18 and 60 years (inclusive). * Exclusion Criteria: * Presence of systemic diseases or other contraindications to tooth extraction surgery. * Known or suspected current malignancy. * History of radiation therapy to the head and neck region. * History of chemotherapy within 5 years prior to surgery. * Smoking \> 15 cigarettes per day. * Subjects with mental or neurological disorders, or otherwise unable to provide informed consent.

Contact & Investigator

Principal Investigator

Ye Wu, Ph.D.

PRINCIPAL INVESTIGATOR

Stomatological Hospital Affiliated with Fujian Medical University

Frequently Asked Questions

Who can join the NCT07779421 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Alveolar Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07779421 currently recruiting?

Yes, NCT07779421 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stomatological Hospital Affiliated with Fujian Medical University to inquire about joining.

Where is the NCT07779421 trial being conducted?

This trial is being conducted at Fuzhou, China.

Who is sponsoring the NCT07779421 clinical trial?

NCT07779421 is sponsored by Stomatological Hospital Affiliated with Fujian Medical University. The principal investigator is Ye Wu, Ph.D. at Stomatological Hospital Affiliated with Fujian Medical University. The trial plans to enroll 136 participants.

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