Implant Stability and OsseointegrationDAGNCT07060859
Topical Dexamethasone, Ascorbic Acid, and BGP for Enhancing Implant Osseointegration
A study testing Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate in people with Implant Stability and Osseointegration, run by Manar Ziad Foura-Matar at 1 site in Palestinian Territories.
Trial summary
The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Implant Stability and Osseointegration
- What is being tested?
- Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Jan 2023to 30 Sep 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provided a written informed consent prior to initiation of any study procedures.
- Was able to understand and agrees to comply with planned study procedures and be available for all study visits.
- Agreed to undergo cone beam computed tomography (CBCT) imaging.
- Was a male or non-pregnant female, >/= to 18 years of age at the time of enrollment.
- Was in good general health, free medical diseases.
- Had two hopeless teeth for minimum required extraction for the purpose of implant-supported restorations.
Who cannot join
- Was undergoing chronic treatment with any medication known to affect oral status and bone turnover.
- Had a contraindication for surgical treatment.
- Was suffering from a known psychological disorder.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al Azhar University - Faculty of Dentistry - Gaza
Gaza, Gaza Strip
About this study
Official title: The Influence of The Topical Combined Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate on Implant Osseointegration: A Randomized Clinical Trial
The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. The main question it aimed to answer was:
Did the combined topical use of these agents improve implant stability during the healing phase?
Read more
Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.
Participants:
Underwent dental implant surgery.
Received both the topical treatment and the standard procedure, applied to different implant sites.
Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.
Read the detailed description
This randomized clinical trial was conducted to investigate the effect of the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate on the osseointegration of dental implants. The rationale behind the study was based on existing evidence suggesting that these agents may enhance bone healing, reduce inflammation, and support mineralization when applied locally.
Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.
Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.
No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.
- Conditions
- Implant Stability and Osseointegration
- Being tested
- Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate
- Keywords
- dexamethasone, ascorbic acid, β-sodium glycerophosphate, osseointegration, implant stability quotient, implant stability, resonance frequency analysis, osteogenic inducer, Immediate dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium GlycerophosphateDrug
A topical combination of dexamethasone (anti-inflammatory), ascorbic acid (antioxidant), and β-sodium glycerophosphate (mineralization support) was applied directly to the implant site during surgery. The intervention aimed to enhance early osseointegration by modulating local biological responses.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Test) | Experimental | Participants received a dental implant with the topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate during surgery. Receives: Drug: Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate |
| Control | No intervention | Participants received a dental implant using the standard surgical procedure without any topical application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Implant Stability Measured by Implant Stability Quotient (ISQ) Using Resonance Frequency Analysis (RFA)
Implant stability will be assessed using resonance frequency analysis (RFA), with results reported as Implant Stability Quotient (ISQ) values. The ISQ scale ranges from 1 (lowest stability) to 100 (highest stability). Higher ISQ values indicate better implant stability and osseointegration.
Measured: At baseline (day of surgery), 4 weeks, 8 weeks, and 16 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start15 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant Stability and OsseointegrationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study followed a split-mouth design, analyzed using a parallel assignment model at the implant level. Each participant received two dental implants: one implant served as the intervention site and received a topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate, while the other implant served as the control site and received standard placement without any topical application. Both implants were placed during the same surgical session, allowing for intra-patient comparison under identical clinical and systemic conditions. Implant stability was assessed at multiple time points using resonance frequency analysis (RFA).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manar Ziad Foura-Matar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manar Ziad Foura-Matar, Al-Azhar University - Gaza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060859
- Sponsor's protocol ID
- DAG-RCT-2023
- Acronym
- DAG
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to confidentiality considerations and the absence of a formal data-sharing infrastructure. The study was not initially designed with data sharing in scope.
Publications
Foura-Matar M, Melad H, Taha M. The Influence of the Topical Combined Application of Dexamethasone, Ascorbic Acid, and beta-Sodium Glycerophosphate on Implant Osseointegration: A Split-Mouth Randomized Clinical Trial. Int J Dent. 2026 Jul 23;2026:5957866. doi: 10.1155/ijod/5957866. eCollection 2026.
PubMed 42494798
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of The Topical Combined Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate on Implant Osseointegration: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07060859
- Acronym / sponsor ID
- DAG / DAG-RCT-2023
- Conditions
- Implant Stability and Osseointegration
- Keywords
- dexamethasone, ascorbic acid, β-sodium glycerophosphate, osseointegration, implant stability quotient, implant stability, resonance frequency analysis, osteogenic inducer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Manar Ziad Foura-MatarUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Jul 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.
The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. The main question it aimed to answer was:
Did the combined topical use of these agents improve implant stability during the healing phase?
Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.
Participants:
Underwent dental implant surgery.
Received both the topical treatment and the standard procedure, applied to different implant sites.
Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.
Detailed description
This randomized clinical trial was conducted to investigate the effect of the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate on the osseointegration of dental implants. The rationale behind the study was based on existing evidence suggesting that these agents may enhance bone healing, reduce inflammation, and support mineralization when applied locally.
Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.
Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.
No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study followed a split-mouth design, analyzed using a parallel assignment model at the implant level. Each participant received two dental implants: one implant served as the intervention site and received a topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate, while the other implant served as the control site and received standard placement without any topical application. Both implants were placed during the same surgical session, allowing for intra-patient comparison under identical clinical and systemic conditions. Implant stability was assessed at multiple time points using resonance frequency analysis (RFA).
| Arm | Type | Receives |
|---|---|---|
| Intervention (Test) | Experimental | Drug: Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium GlycerophosphateParticipants received a dental implant with the topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate during surgery. |
| Control | No intervention | –Participants received a dental implant using the standard surgical procedure without any topical application. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provided a written informed consent prior to initiation of any study procedures.
- Was able to understand and agrees to comply with planned study procedures and be available for all study visits.
- Agreed to undergo cone beam computed tomography (CBCT) imaging.
- Was a male or non-pregnant female, >/= to 18 years of age at the time of enrollment.
- Was in good general health, free medical diseases.
Key exclusion criteria (3 listed)
- Was undergoing chronic treatment with any medication known to affect oral status and bone turnover.
- Had a contraindication for surgical treatment.
- Was suffering from a known psychological disorder.
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 |
|---|---|---|
| Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium GlycerophosphateA topical combination of dexamethasone (anti-inflammatory), ascorbic acid (antioxidant), and β-sodium glycerophosphate (mineralization support) was applied directly to the implant site during surgery. The intervention aimed to enhance early osseointegration by modulating local biological responses. | Drug | Intervention (Test) |
Primary outcome
Change in Implant Stability Measured by Implant Stability Quotient (ISQ) Using Resonance Frequency Analysis (RFA)
Time frame: At baseline (day of surgery), 4 weeks, 8 weeks, and 16 weeks post-surgery
Implant stability will be assessed using resonance frequency analysis (RFA), with results reported as Implant Stability Quotient (ISQ) values. The ISQ scale ranges from 1 (lowest stability) to 100 (highest stability). Higher ISQ values indicate better implant stability and osseointegration.
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 15 Jul 2025.
- Derived from this study: PubMed 42494798Foura-Matar M, Melad H, Taha M. The Influence of the Topical Combined Application of Dexamethasone, Ascorbic Acid, and beta-Sodium Glycerophosphate on Implant Osseointegration: A Split-Mouth Randomized Clinical Trial. Int J Dent. 2026 Jul 23;2026:5957866. doi: 10.1155/ijod/5957866. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to confidentiality considerations and the absence of a formal data-sharing infrastructure. The study was not initially designed with data sharing in scope.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate in people with Implant Stability and Osseointegration, run by Manar Ziad Foura-Matar at 1 site in Palestinian Territories.
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 6 inclusion and 3 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 15 Jul 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 Palestinian Territories. 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?
Change in Implant Stability Measured by Implant Stability Quotient (ISQ) Using Resonance Frequency Analysis (RFA) (time frame: At baseline (day of surgery), 4 weeks, 8 weeks, and 16 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07060859, which also lists 1 linked publication.
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 15 Jul 2025.