Dental ImplantsNCT07844928
Blue®M Gel Versus Hyaluronic Acid for Stability of Immediately Loaded Dental Implants
A study testing Blue®M Gel and Hyaluronic Acid in people with Dental Implants and Immediate Dental Implant Loading, run by Mansoura University.
Trial summary
This randomized controlled clinical trial aims to compare the effect of topical oxygen therapy (Blue®M Gel) and hyaluronic acid on the stability of immediately loaded dental implants placed in the posterior maxilla. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dental Implants, Immediate Dental Implant Loading, Implant Stability
- What is being tested?
- Blue®M Gel and Hyaluronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2026to 12 Mar 2027
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-45 years.
- Patients with one or more missing teeth in the posterior maxilla.
- Adequate bone volume (width ≥ 6 mm and height ≥ 12 mm from maxillary sinus floor).
- Good oral hygiene and motivation for oral rehabilitation.
Who cannot join
- Patients with systemic or local diseases contraindicating implant surgery.
- Smokers.
- History of radiotherapy or chemotherapy.
- Pregnant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Topical Oxygen Therapy (Blue®M Gel) Versus Hyaluronic Acid on the Stability of Immediately Loaded Dental Implants in the Posterior Maxilla
This randomized controlled clinical trial aims to compare the effect of topical oxygen therapy (Blue®M Gel) and hyaluronic acid on the stability of immediately loaded dental implants placed in the posterior maxilla. Twenty-four dental implants will be placed in eligible patients and randomly assigned to one of three groups: control implants without surface treatment, implants immersed in Blue®M Gel before placement, and implants immersed in hyaluronic acid gel before placement.
Implant stability will be evaluated using resonance frequency analysis immediately after implant placement and during follow-up. Clinical healing outcomes, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection, will also be assessed. Radiographic evaluation of crestal bone level changes will be performed using cone beam computed tomography (CBCT). The study seeks to determine whether topical oxygen therapy or hyaluronic acid can improve implant stability and peri-implant healing in the posterior maxilla.
Read the detailed description
Dental implants are a predictable treatment option for the replacement of missing teeth. However, implant placement in the posterior maxilla remains challenging because of reduced bone density, sinus pneumatization, and limited residual bone volume. Achieving adequate primary stability is particularly important when immediate loading protocols are used.
Blue®M Gel is an oxygen-releasing topical gel that provides controlled delivery of active oxygen and contains lactoferrin, which may support wound healing, reduce bacterial load, and enhance tissue regeneration. Hyaluronic acid is a naturally occurring glycosaminoglycan that plays an important role in tissue repair, modulation of inflammation, and bone regeneration. Both materials have demonstrated beneficial effects on soft and hard tissue healing.
This study will be conducted as a randomized controlled clinical trial including patients requiring replacement of one or more missing teeth in the posterior maxilla. A total of 24 implants will be inserted and randomly allocated into three equal groups:
Group I: Immediate loaded implants without surface treatment (control group).
Group II: Immediate loaded implants immersed in Blue®M Gel before placement.
Group III: Immediate loaded implants immersed in hyaluronic acid gel before placement.
All implants will be placed using a standardized surgical protocol. Implant stability will be measured immediately after placement and at follow-up intervals using resonance frequency analysis and Implant Stability Quotient (ISQ) values. Clinical healing parameters will be evaluated postoperatively, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection. Radiographic assessment of crestal bone level changes will be performed using CBCT imaging.
The primary objective of the study is to compare the effect of topical oxygen therapy and hyaluronic acid on implant stability in immediately loaded dental implants placed in the posterior maxilla. Secondary objectives include evaluation of peri-implant soft tissue healing and radiographic bone changes during the follow-up period.
- Being tested
- Blue®M Gel, Hyaluronic Acid
- Keywords
- Blue®M Gel, Topical Oxygen Therapy, Hyaluronic Acid, Implant Stability Quotient, Osseointegration, CBCT Bone Level, Immediately Loaded Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue®M GelOther
Topical oxygen-releasing gel used for implant surface conditioning prior to placement to enhance healing and implant stability.
Hyaluronic AcidOther
Viscoelastic gel used for implant surface immersion prior to placement to enhance soft and hard tissue healing and improve implant stability.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients will receive immediately loaded dental implants without any surface conditioning or immersion in adjunctive agents prior to placement in the posterior maxilla |
| Blue®M Gel Group | Experimental | Patients will receive immediately loaded dental implants immersed in topical oxygen therapy gel (Blue®M Gel) prior to placement in the posterior maxilla Receives: Other: Blue®M Gel |
| Hyaluronic Acid Group | Experimental | Patients will receive immediately loaded dental implants immersed in hyaluronic acid gel prior to placement in the posterior maxilla. Receives: Other: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ)
Primary implant stability will be measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values.
Measured: Immediately after implant placement and follow up visits during the 6 months
Secondary outcomes (1)
Marginal (crestal) bone level changes around the dental implants
assessed radiographically using standardized periapical radiographs during the 6-month follow-up period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start12 Sep 2026 (estimated)
- Primary completion12 Feb 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Participants will be randomly assigned into three parallel groups receiving different implant surface treatments prior to immediate loading in the posterior maxilla.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad awad, Mansoura University
- Investigators
- Fahad A Alqahtani, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844928
- Sponsor's protocol ID
- MS.26.02.143
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 28 Sep 2026
- 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 ethical and confidentiality considerations. The dataset contains sensitive clinical and radiographic information related to dental implant patients, and sharing may compromise patient privacy. Additionally, no plan for external data sharing or public repository submission has been established for this study.
Publications
Shaheen MY, Abas I, Basudan AM, Alghamdi HS. Local Oxygen-Based Therapy (blue(R)m) for Treatment of Peri-Implant Disease: Clinical Case Presentation and Review of Literature about Conventional Local Adjunct Therapies. Medicina (Kaunas). 2024 Mar 8;60(3):447. doi: 10.3390/medicina60030447.
PubMed 38541173Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
PubMed 33634616Elsayed MD. Biomechanical factors that influence the bone-implant interface. Res Rep Oral Maxillofac Surg. 2019;3(1):1-14.
Warreth A, Ibieyou N, O'Leary RB, Cremonese M, Abdulrahim M. Dental implants: an overview. Dent Update. 2017;44(7):596-620.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Oxygen Therapy (Blue®M Gel) Versus Hyaluronic Acid on the Stability of Immediately Loaded Dental Implants in the Posterior Maxilla
- ClinicalTrials.gov ID
- NCT07844928
- Acronym / sponsor ID
- MS.26.02.143
- Keywords
- Blue®M Gel, Topical Oxygen Therapy, Hyaluronic Acid, Implant Stability Quotient, Osseointegration, CBCT Bone Level, Immediately Loaded Implants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Sep 2026 (estimated)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 28 Sep 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.
This randomized controlled clinical trial aims to compare the effect of topical oxygen therapy (Blue®M Gel) and hyaluronic acid on the stability of immediately loaded dental implants placed in the posterior maxilla. Twenty-four dental implants will be placed in eligible patients and randomly assigned to one of three groups: control implants without surface treatment, implants immersed in Blue®M Gel before placement, and implants immersed in hyaluronic acid gel before placement.
Implant stability will be evaluated using resonance frequency analysis immediately after implant placement and during follow-up. Clinical healing outcomes, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection, will also be assessed. Radiographic evaluation of crestal bone level changes will be performed using cone beam computed tomography (CBCT). The study seeks to determine whether topical oxygen therapy or hyaluronic acid can improve implant stability and peri-implant healing in the posterior maxilla.
Detailed description
Dental implants are a predictable treatment option for the replacement of missing teeth. However, implant placement in the posterior maxilla remains challenging because of reduced bone density, sinus pneumatization, and limited residual bone volume. Achieving adequate primary stability is particularly important when immediate loading protocols are used.
Blue®M Gel is an oxygen-releasing topical gel that provides controlled delivery of active oxygen and contains lactoferrin, which may support wound healing, reduce bacterial load, and enhance tissue regeneration. Hyaluronic acid is a naturally occurring glycosaminoglycan that plays an important role in tissue repair, modulation of inflammation, and bone regeneration. Both materials have demonstrated beneficial effects on soft and hard tissue healing.
This study will be conducted as a randomized controlled clinical trial including patients requiring replacement of one or more missing teeth in the posterior maxilla. A total of 24 implants will be inserted and randomly allocated into three equal groups:
Group I: Immediate loaded implants without surface treatment (control group).
Group II: Immediate loaded implants immersed in Blue®M Gel before placement.
Group III: Immediate loaded implants immersed in hyaluronic acid gel before placement.
All implants will be placed using a standardized surgical protocol. Implant stability will be measured immediately after placement and at follow-up intervals using resonance frequency analysis and Implant Stability Quotient (ISQ) values. Clinical healing parameters will be evaluated postoperatively, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection. Radiographic assessment of crestal bone level changes will be performed using CBCT imaging.
The primary objective of the study is to compare the effect of topical oxygen therapy and hyaluronic acid on implant stability in immediately loaded dental implants placed in the posterior maxilla. Secondary objectives include evaluation of peri-implant soft tissue healing and radiographic bone changes during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned into three parallel groups receiving different implant surface treatments prior to immediate loading in the posterior maxilla.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients will receive immediately loaded dental implants without any surface conditioning or immersion in adjunctive agents prior to placement in the posterior maxilla |
| Blue®M Gel Group | Experimental | Other: Blue®M GelPatients will receive immediately loaded dental implants immersed in topical oxygen therapy gel (Blue®M Gel) prior to placement in the posterior maxilla |
| Hyaluronic Acid Group | Experimental | Other: Hyaluronic AcidPatients will receive immediately loaded dental implants immersed in hyaluronic acid gel prior to placement in the posterior maxilla. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-45 years.
- Patients with one or more missing teeth in the posterior maxilla.
- Adequate bone volume (width ≥ 6 mm and height ≥ 12 mm from maxillary sinus floor).
- Good oral hygiene and motivation for oral rehabilitation.
Key exclusion criteria (4 listed)
- Patients with systemic or local diseases contraindicating implant surgery.
- Smokers.
- History of radiotherapy or chemotherapy.
- Pregnant.
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 |
|---|---|---|
| Blue®M GelTopical oxygen-releasing gel used for implant surface conditioning prior to placement to enhance healing and implant stability. | Other | Blue®M Gel Group |
| Hyaluronic AcidViscoelastic gel used for implant surface immersion prior to placement to enhance soft and hard tissue healing and improve implant stability. | Other | Hyaluronic Acid Group |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: Immediately after implant placement and follow up visits during the 6 months
Primary implant stability will be measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values.
1 secondary outcome
Marginal (crestal) bone level changes around the dental implants
Time frame: 6 months
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 28 Sep 2026.
- Background: PubMed 38541173Shaheen MY, Abas I, Basudan AM, Alghamdi HS. Local Oxygen-Based Therapy (blue(R)m) for Treatment of Peri-Implant Disease: Clinical Case Presentation and Review of Literature about Conventional Local Adjunct Therapies. Medicina (Kaunas). 2024 Mar 8;60(3):447. doi: 10.3390/medicina60030447.
- Background: PubMed 33634616Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
- BackgroundElsayed MD. Biomechanical factors that influence the bone-implant interface. Res Rep Oral Maxillofac Surg. 2019;3(1):1-14.
- BackgroundWarreth A, Ibieyou N, O'Leary RB, Cremonese M, Abdulrahim M. Dental implants: an overview. Dent Update. 2017;44(7):596-620.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and confidentiality considerations. The dataset contains sensitive clinical and radiographic information related to dental implant patients, and sharing may compromise patient privacy. Additionally, no plan for external data sharing or public repository submission has been established for this study.
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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.
Fahad A Alqahtani principal investigator
Faculty of Dentistry, Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing Blue®M Gel and Hyaluronic Acid in people with Dental Implants and Immediate Dental Implant Loading, run by Mansoura University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Fahad A Alqahtani, BDS (+201558123728, fa.3wad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) (time frame: Immediately after implant placement and follow up visits during the 6 months). 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 NCT07844928, which also lists 4 linked publications.
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 28 Sep 2026.