Peri-implant Bone Healing and OsseointegrationNCT07156799
Kaempferol Gel , Alkaline Phosphatase Activity , Bone Density Around Dental Implants
A study testing Kaempferol Gel in people with Peri-implant Bone Healing and Osseointegration, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Kaempferol gel was tested as a local adjunct during implant placement in 30 patients. Compared to controls, the Kaempferol group showed significantly higher ALP activity at 2 and 4 weeks and greater bone density gain after 6 months (40.73% vs. 33.21%). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Bone Healing and Osseointegration
- What is being tested?
- Kaempferol Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2023to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one missing maxillary posterior tooth with a healed ridge
Who cannot join
- Previous bone grafting at the implant site.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Cairo Governorate
About this study
Official title: Influence of Kaempferol Gel on Alkaline Phosphatase Activity and Bone Density Around Dental Implants: A Randomized Controlled Clinical Trial
Kaempferol gel was tested as a local adjunct during implant placement in 30 patients. Compared to controls, the Kaempferol group showed significantly higher ALP activity at 2 and 4 weeks and greater bone density gain after 6 months (40.73% vs. 33.21%). These findings suggest Kaempferol enhances early bone remodeling, improves peri-implant bone quality, and may allow earlier implant loading.
Read the detailed description
This randomized controlled clinical trial investigated the effect of Kaempferol gel, a natural antioxidant and bone-healing compound, on dental implant healing in the maxillary posterior region. Thirty patients were divided into two groups: one received Kaempferol gel during implant placement, while the other did not.
The study measured alkaline phosphatase (ALP) activity in peri-implant crevicular fluid at 1, 2, and 4 weeks, and bone density using CBCT at baseline and 6 months. Results showed that Kaempferol significantly boosted ALP activity at 2 and 4 weeks, suggesting faster bone remodeling. At 6 months, bone density improved in both groups, but the Kaempferol group showed a greater increase (40.73% vs. 33.21%).
In conclusion, Kaempferol gel enhanced early bone healing and improved bone density around implants, indicating its potential as a cost-effective, biocompatible adjunct to accelerate osseointegration and possibly allow earlier implant loading, particularly in patients with poor bone quality.
- Being tested
- Kaempferol Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaempferol GelDrug
Also called Flavinoids
Local topical application of Kaempferol gel into the implant site during one-stage delayed implant placement to enhance peri-implant bone healing and osseointegration.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | kaempferol gel application and implant placement Receives: Drug: Kaempferol Gel |
| control group | No intervention | implant placement with out application of kaempferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
alkaline phosphatase level
Change in alkaline phosphatase (ALP) activity measured in peri-implant crevicular fluid (PICF) using ELISA to evaluate early bone remodeling activity.
Measured: at baseline, 1,2, 4 weeks
Secondary outcomes (1)
Bone density around implants
Change in peri-implant bone density assessed by cone beam computed tomography (CBCT) at the implant site
Measured: Baseline and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start5 Jun 2023
- Primary completion10 Jun 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Bone Healing and OsseointegrationStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Abdelgawad Mohamed, Al-Azhar University
- Investigators
- Dr. Nora Abdelgawad, Principal investigator, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156799
- Sponsor's protocol ID
- OMPDR-103-2F
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Kaempferol Gel on Alkaline Phosphatase Activity and Bone Density Around Dental Implants: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07156799
- Acronym / sponsor ID
- OMPDR-103-2F
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 5 Sep 2025 (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.
Kaempferol gel was tested as a local adjunct during implant placement in 30 patients. Compared to controls, the Kaempferol group showed significantly higher ALP activity at 2 and 4 weeks and greater bone density gain after 6 months (40.73% vs. 33.21%). These findings suggest Kaempferol enhances early bone remodeling, improves peri-implant bone quality, and may allow earlier implant loading.
Detailed description
This randomized controlled clinical trial investigated the effect of Kaempferol gel, a natural antioxidant and bone-healing compound, on dental implant healing in the maxillary posterior region. Thirty patients were divided into two groups: one received Kaempferol gel during implant placement, while the other did not.
The study measured alkaline phosphatase (ALP) activity in peri-implant crevicular fluid at 1, 2, and 4 weeks, and bone density using CBCT at baseline and 6 months. Results showed that Kaempferol significantly boosted ALP activity at 2 and 4 weeks, suggesting faster bone remodeling. At 6 months, bone density improved in both groups, but the Kaempferol group showed a greater increase (40.73% vs. 33.21%).
In conclusion, Kaempferol gel enhanced early bone healing and improved bone density around implants, indicating its potential as a cost-effective, biocompatible adjunct to accelerate osseointegration and possibly allow earlier implant loading, particularly in patients with poor bone quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Kaempferol Gelkaempferol gel application and implant placement |
| control group | No intervention | –implant placement with out application of kaempferol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least one missing maxillary posterior tooth with a healed ridge
Key exclusion criteria (1 listed)
- Previous bone grafting at the implant site.
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 |
|---|---|---|
| Kaempferol GelAlso: FlavinoidsLocal topical application of Kaempferol gel into the implant site during one-stage delayed implant placement to enhance peri-implant bone healing and osseointegration. | Drug | test group |
Primary outcome
alkaline phosphatase level
Time frame: at baseline, 1,2, 4 weeks
Change in alkaline phosphatase (ALP) activity measured in peri-implant crevicular fluid (PICF) using ELISA to evaluate early bone remodeling activity.
1 secondary outcome
Bone density around implants
Time frame: Baseline and 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Recruiting
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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. This study is not recruiting at the moment.
Dr. Nora Abdelgawad principal investigator
Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaempferol Gel in people with Peri-implant Bone Healing and Osseointegration, run by Al-Azhar University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Sep 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alkaline phosphatase level (time frame: at baseline, 1,2, 4 weeks). 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 5 Sep 2025.