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RECRUITING
NCT07889674
PHASE2/PHASE3

Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement

Sponsor: Future University in Egypt

View on ClinicalTrials.gov

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.

Official title: Lactoferrin Nanohydrogel as a Therapeutic Adjunct for Enhancing Soft Tissue Healing and Implant Stability in Immediate Implant Placement. A Randomized Clinical Trial

Key Details

Gender

All

Age Range

25 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06-05

Completion Date

2027-01-25

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

4% bovine lactoferrin nanohydrogel

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.

Locations (1)

Future University in Egypt, Faculty of Oral and Dental Medicine, Department of Oral and Maxillofacial Surgery

Cairo, Cairo Governorate, Egypt