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NCT07889674
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Conditions: Immediate Dental Implant Placement Dental Implant Stability Soft Tissue Healing Bone Regeneration Lactoferrin Nanohydrogel, Dental Implant Stability - Bone Regeneration
Sex: All
Ages: 25 Years – 55 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 20
Sponsor: Future University in Egypt
Location: Future University in Egypt, Faculty of Oral and Dental Medicine, Department of Oral and Maxillofacial Surgery Cairo Cairo Governorate
Summary
The goal of this randomized clinical trial is to evaluate whether local application of a 4% bovine lactoferrin nanohydrogel improves soft tissue healing, bone healing, and implant stability following immediate dental implant placement in mandibular molar sites.
The main questions it aims to answer are:
Does the use of a Lactoferrin Nano-Hydrogel in combination with healing abutments enhance bone and soft tissue regeneration, reduce peri-implant inflammation, and improve the success rate of immediate implant placement in mandibular molars compared to conventional healing methods?
Researchers will compare immediate implant placement with local application of the 4% bovine lactoferrin nanohydrogel to the same surgical procedure without the nanohydrogel to evaluate differences in bone healing, marginal bone levels, implant stability, soft tissue healing, clinical inflammation, and postoperative pain.
Eligibility Criteria
Inclusion Criteria:
1. Patients aged between 25 to 55 years.
2. Patients requiring immediate implant placement in posterior mandibular teeth Confirmed via CBCT of sufficient bone quantity, including buccal plate bone, bone apical to the root apex, and lingual bone, with adequate proximal bone to avoid encroachment on adjacent roots.
3. Evaluation of risks and the ability to position the implant in an ideal location
4. Achieving ideal primary implant stability (35-45 N/cm), influenced by bone
5. Good systemic health (ASA I or II).
6. Sufficient bone volume to accommodate the implant without the need for additional grafting.
7. Willingness to participate and sign informed consent.
Exclusion Criteria:
* 1\. Heavy smokers (more than 10 cigarettes daily within the past 6 months). 2. Uncontrolled systemic diseases (e.g., diabetes mellitus, cardiovascular disease).
3\. Active oral infections or poor oral hygiene. 4. Pregnant or lactating women. 5. Radiation therapy or chemotherapy within the last 6 months. 6. Congenital bone diseases. 7. Osteoporosis or any diseases affecting bone density.
Source: ClinicalTrials.gov (NCT07889674). StuddyBuddy aggregates publicly available trial information.