Lactoferrin Gel for Healing and Implant Stability in Immediate Mandibular Molars
Official title: Lactoferrin Nanohydrogel as a Therapeutic Adjunct for Enhancing Soft Tissue Healing and Implant Stability in Immediate Implant Placement. A Randomized Clinical Trial
Run by Future University in Egypt · NCT07889674 · Data updated 2026-11-12
A 4% bovine lactoferrin nanohydrogel is being tested to see if it helps soft tissue and bone heal better and improve implant stability after immediate mandibular molar implants.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Future University in Egypt Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | June 5, 2026 |
| Main results expected | December 29, 2026 |
| Study ends | January 25, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07889674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 25–55 requiring immediate posterior mandibular implants with adequate bone and primary stability (35–45 N/cm), and good overall health (ASA I–II).
✕Probably not a fit
Patients with heavy smoking, uncontrolled systemic disease, active oral infections, pregnancy, prior head/neck radiation or chemotherapy, or insufficient bone may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares immediate implant placement in the mandible using a 4% bovine lactoferrin nanohydrogel with the same procedure without the gel. Outcomes include soft tissue healing, peri-implant inflammation, marginal bone levels, implant stability, and postoperative pain. It targets patients aged 25–55 with good systemic health and adequate bone at posterior mandibular sites. The study spans Phase 2 to Phase 3 to assess safety and efficacy of the hydrogel as an adjunct to standard care.
Why it matters
Potential benefit: If successful, patients may experience faster soft tissue and bone healing and greater implant stability after immediate implantation.
How similar studies have gone: Evidence in this area is limited and this trial will test the approach in a clinically relevant setting.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Future University in Egypt, Faculty of Oral and Dental Medicine, Department of Oral and Maxillofacial Surgery
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: sara M Alali, MSc
- Email: mksara660@gmail.com
- Phone: +201119032297
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.