A Phase 2/3 interventional study of 4% bovine lactoferrin nanohydrogel in Immediate Dental Implant Placement Dental Implant Stability Soft Tissue Healing Bone Regeneration Lactoferrin Nanohydrogel and Dental Implant Stability - Bone Regeneration, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Future University in Egypt · Phase 2/3, Interventional, and Treatment
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.
Immediate implant placement is a treatment option following tooth extraction; however, achieving predictable peri-implant soft tissue and bone healing remains a clinical challenge. Lactoferrin has potential antimicrobial and tissue-healing properties that may support postoperative healing.
Despite these potential benefits, clinical evidence regarding the use of locally applied bovine lactoferrin nanohydrogel during immediate dental implant placement remains limited. Further clinical investigation is needed to evaluate its effects on healing outcomes and implant stability.
This randomized controlled clinical trial will evaluate a 4% bovine lactoferrin nanohydrogel in patients receiving immediate mandibular molar implants. Clinical and radiographic outcomes, including soft tissue healing, peri-implant inflammation, marginal bone level changes, implant stability, and postoperative pain, will be assessed and compared with a control group receiving the same implant procedure without the nanohydrogel.
Future University in Egypt is the lead sponsor of 103 studies on the registry; 30 are open to participants now.
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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.
Participants in this group will undergo immediate implant placement in mandibular molar extraction sites, followed by customize healing abutment placement. A total of 1.5 mL of 4% bovine lactoferrin nanohydrogel will be applied locally as follows: 0.5 mL into the osteotomy, 0.5 mL around the dental implant, and 0.5 mL onto the customize healing abutment. The nanohydrogel is formulated with phospholipids, Carbopol, triethanolamine, and Tween 80 by the Department of Pharmaceutics, Faculty of Pharmacy, Future University in Egypt. Participants will be followed up immediately after surgery and at 7 days, and 3 months to assess implant stability, bone changes, soft tissue healing, peri-implant inflammation, and pain.
Drug: 4% bovine lactoferrin nanohydrogel
Participants in this group will undergo immediate implant placement in mandibular molar extraction sites, followed by customize healing abutment placement, without the application of lactoferrin nanohydrogel. The surgical procedure, implant placement protocol, and postoperative care will be the same as those in the experimental group, except that no nanohydrogel will be used. Participants will be followed up immediately after surgery and at 7 days, and 3 months to assess implant stability, bone changes, soft tissue healing, peri-implant inflammation, and pain.
A 4% bovine lactoferrin nanohydrogel formulated with phospholipids, Carbopol, triethanolamine, and Tween 80 will be administered locally during immediate implant placement. A total volume of 1.5 mL will be applied once per participant during surgery, distributed as follows: 0.5 mL into the osteotomy, 0.5 mL around the dental implant, and 0.5 mL onto the healing abutment. The intervention will be administered as a single local application during the surgical procedure. No additional postoperative applications of the nanohydrogel are planned. Participants will be followed up at 7 days, and 3 months after surgery to assess clinical and radiographic outcomes.
Change in Peri-Implant Bone Regeneration
Bone changes around the dental implant will be assessed radiographically using cone-beam computed tomography (CBCT). Bone regeneration will be evaluated by comparing the selected radiographic bone measurements between the intervention and control groups from baseline to the 3-month follow-up. The same imaging modality and measurement method will be used consistently for all participants.
Time frame: Immediately after implant placement (baseline) and at 3 months postoperatively.
Change in Dental Implant Stability
Implant stability will be assessed using the AnyCheck device. Stability measurements will be recorded after implant placement and at the 3-month follow-up. Changes in the recorded stability values between baseline and follow-up will be compared between the lactoferrin nanohydrogel and control groups.
Time frame: Immediately after implant placement and at 3 months postoperatively.
Change in Peri-Implant Marginal Bone Level
Marginal bone levels adjacent to the implant will be measured radiographically in millimeters (mm) using Cbct radiographs. The change in marginal bone level from the immediate postoperative baseline to the 3-month follow-up will be compared between the intervention and control groups.
Time frame: Immediately after implant placement (baseline) and at 3 months postoperatively.
Postoperative Pain Intensity
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded and compared between participants in the lactoferrin nanohydrogel and control groups.
Time frame: Immediately after surgery and at 7 days postoperatively.
Soft Tissue Healing Following Immediate Implant Placement
Soft tissue healing will be assessed clinically using the Wound Healing Index (WHI) described by Landry et al. The healing status of the surgical site will be evaluated and recorded, and scores will be compared between the lactoferrin nanohydrogel and control groups. Higher scores will be interpreted according to the selected index scoring criteria.
Time frame: At 7 days after implant placement.
Plan to share: No
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