Dental ImplantPhase 2/3LFNCT07889674
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
A Phase 2/3 study testing 4% bovine lactoferrin nanohydrogel in people with Dental Implant and Wound Healing, run by Future University in Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Dental Implant, Wound Healing
- What is being tested?
- 4% bovine lactoferrin nanohydrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2026to 25 Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 25 to 55 years.
- 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.
- Evaluation of risks and the ability to position the implant in an ideal location
- Achieving ideal primary implant stability (35-45 N/cm), influenced by bone
- Good systemic health (ASA I or II).
- Sufficient bone volume to accommodate the implant without the need for additional grafting.
- Willingness to participate and sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt, Faculty of Oral and Dental Medicine, Department of Oral and Maxillofacial Surgery
Cairo, Cairo Governorate, 11835
sara M Alali, MSc, +201119032297, mksara660@gmail.com
About this study
Official title: Lactoferrin Nanohydrogel as a Therapeutic Adjunct for Enhancing Soft Tissue Healing and Implant Stability in Immediate Implant Placement. A Randomized Clinical Trial
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Dental Implant, Wound Healing
- Being tested
- 4% bovine lactoferrin nanohydrogel
- Keywords
- Immediate implant, Lactoferrin, Implant Stability, Bone Reheneration, Marginal Bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% bovine lactoferrin nanohydrogelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin Nanohydrogel Group | Experimental | 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. Receives: Drug: 4% bovine lactoferrin nanohydrogel |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peri-Implant Bone Regeneration
Peri-implant bone changes will be assessed using cone-beam computed tomography (CBCT) immediately after implant placement and at the 3-month follow-up. Radiographic bone fill and grayscale values within a predefined region of interest around the implant will be evaluated using the same imaging and measurement protocol at both time points. Changes from immediately after implant placement to 3 months will be compared between the intervention and control groups. CBCT grayscale values will not be reported as Hounsfield units unless a validated calibration method is used.
Measured: Immediately after implant placement and at 3 months postoperatively.
Change in Dental Implant Stability
Dental implant stability will be assessed using the AnyCheck device. Measurements will be recorded immediately after implant placement and at the 3-month follow-up. Implant stability will be reported using the device-generated implant stability value on its defined measurement scale. Changes from baseline to 3 months will be compared between the lactoferrin nanohydrogel and control groups. The full scale name, minimum and maximum values, and interpretation of higher values will follow the device specifications.
Measured: Immediately after implant placement and at 3 months postoperatively.
Change in Peri-Implant Marginal Bone Level
Peri-implant marginal bone levels will be assessed using cone-beam computed tomography (CBCT). The distance from the implant platform to the first visible bone-to-implant contact will be measured in millimeters (mm) at the mesial and distal aspects of the implant immediately after implant placement and at the 3-month follow-up. Measurements will be performed using a consistent imaging orientation and measurement protocol. Changes from baseline to 3 months will be compared between the lactoferrin nanohydrogel and control groups. An increase in this distance indicates greater marginal bone loss.
Measured: Immediately after implant placement and at 3 months postoperatively.
Secondary outcomes (2)
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Pain scores will be recorded immediately after surgery and at 7 days postoperatively and compared between the lactoferrin nanohydrogel and control groups.
Measured: 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 (Landry), with scores ranging from 1 to 5. Higher scores indicate better wound healing, while lower scores indicate poorer wound healing. The healing status of the surgical site will be evaluated and recorded, and scores will be compared between the lactoferrin nanohydrogel and control groups.
Measured: At 7 days after implant placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start5 Jun 2026
- Primary completion29 Dec 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, parallel-group clinical trial involving two groups of patients undergoing immediate implant placement in mandibular molars. The intervention group will receive a 4% bovine lactoferrin nanohydrogel in addition to implant placement and healing abutment placement. The control group will undergo the same surgical procedure with a healing abutment but without the nanohydrogel. Each participant will be assigned to only one study group and will remain in that group throughout the study. Clinical and radiographic assessments will be conducted immediately after surgery and at 7 days, and 3 months postoperatively to evaluate implant stability, bone changes, soft tissue healing, inflammation, and pain.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed kamal, Future University in Egypt
- Investigators
- Lobna A Aly, Professor, Study chair, Professor of oral and maxillofacial surgery - Faculty of Oral and Dental Medicine- Future university in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889674
- Sponsor's protocol ID
- FUE.REC(8)/1-2026
- Acronym
- LF
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin Nanohydrogel as a Therapeutic Adjunct for Enhancing Soft Tissue Healing and Implant Stability in Immediate Implant Placement. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07889674
- Acronym / sponsor ID
- LF / FUE.REC(8)/1-2026
- Conditions
- Dental Implant, Wound Healing
- Keywords
- Immediate implant, Lactoferrin, Implant Stability, Bone Reheneration, Marginal Bone loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, parallel-group clinical trial involving two groups of patients undergoing immediate implant placement in mandibular molars. The intervention group will receive a 4% bovine lactoferrin nanohydrogel in addition to implant placement and healing abutment placement. The control group will undergo the same surgical procedure with a healing abutment but without the nanohydrogel. Each participant will be assigned to only one study group and will remain in that group throughout the study. Clinical and radiographic assessments will be conducted immediately after surgery and at 7 days, and 3 months postoperatively to evaluate implant stability, bone changes, soft tissue healing, inflammation, and pain.
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin Nanohydrogel Group | Experimental | Drug: 4% bovine lactoferrin nanohydrogelParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged between 25 to 55 years.
- 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.
- Evaluation of risks and the ability to position the implant in an ideal location
- Achieving ideal primary implant stability (35-45 N/cm), influenced by bone
- Good systemic health (ASA I or II).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% bovine lactoferrin nanohydrogelA 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. | Drug | Lactoferrin Nanohydrogel Group |
Primary outcome
Change in Peri-Implant Bone Regeneration
Time frame: Immediately after implant placement and at 3 months postoperatively.
Peri-implant bone changes will be assessed using cone-beam computed tomography (CBCT) immediately after implant placement and at the 3-month follow-up. Radiographic bone fill and grayscale values within a predefined region of interest around the implant will be evaluated using the same imaging and measurement protocol at both time points. Changes from immediately after implant placement to 3 months will be compared between the intervention and control groups. CBCT grayscale values will not be reported as Hounsfield units unless a validated calibration method is used.
Change in Dental Implant Stability
Time frame: Immediately after implant placement and at 3 months postoperatively.
Dental implant stability will be assessed using the AnyCheck device. Measurements will be recorded immediately after implant placement and at the 3-month follow-up. Implant stability will be reported using the device-generated implant stability value on its defined measurement scale. Changes from baseline to 3 months will be compared between the lactoferrin nanohydrogel and control groups. The full scale name, minimum and maximum values, and interpretation of higher values will follow the device specifications.
Change in Peri-Implant Marginal Bone Level
Time frame: Immediately after implant placement and at 3 months postoperatively.
Peri-implant marginal bone levels will be assessed using cone-beam computed tomography (CBCT). The distance from the implant platform to the first visible bone-to-implant contact will be measured in millimeters (mm) at the mesial and distal aspects of the implant immediately after implant placement and at the 3-month follow-up. Measurements will be performed using a consistent imaging orientation and measurement protocol. Changes from baseline to 3 months will be compared between the lactoferrin nanohydrogel and control groups. An increase in this distance indicates greater marginal bone loss.
2 secondary outcomes
Postoperative Pain Intensity
Time frame: Immediately after surgery and at 7 days postoperatively.
Soft Tissue Healing Following Immediate Implant Placement
Time frame: At 7 days after implant placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lobna A Aly, Professor study chair
Professor of oral and maxillofacial surgery - Faculty of Oral and Dental Medicine- Future university in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 4% bovine lactoferrin nanohydrogel in people with Dental Implant and Wound Healing, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sara M Alali, MSc (+201119032297, mksara660@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peri-Implant Bone Regeneration (time frame: Immediately after implant placement and at 3 months postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.