THBC/CGF for Alveolar Bone Regeneration: A Real-World Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorStomatological Hospital Affiliated with Fujian Medical University
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor
- Temperature-sensitive hydroxybutyl chitosan
- Autologous Concentrated Growth Factor
- Natural Healing without Biomaterial Intervention
Treatment groups
136 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov