In Recent Years, There Has Been a Rise in the Use of Immediate Loading ProtocolsNCT06976866
Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla
A study testing implant surgery in people with In Recent Years, There Has Been a Rise in the Use of Immediate Loading Protocols and Dental Implant Stability, run by Amira attia at 1 site in Egypt.
Trial summary
Background: In recent years, there has been a rise in the use of immediate loading protocols; however, the complex anatomy of the posterior maxilla presents challenges. Currently, there is a lack of comparative studies assessing the effects of hyaluronic acid and atorvastatin gel on enhancing bone density in this… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- In Recent Years, There Has Been a Rise in the Use of Immediate Loading Protocols, Dental Implant Stability
- What is being tested?
- implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2023to 14 May 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- patients with one or more missing maxillary posterior teeth
- age ranging from 18 to 45 years
- patient's cooperation
- motivation and good oral hygiene
- adequate occlusion (proper interarch space).
Who cannot join
- individuals with systemic or local diseases that are contraindicative of surgery or implant placement
- pregnant individuals
- individuals with any bone diseases that may impede bone healing
- smokers
- individuals who exhibit parafunctional habits like bruxism and clenching.
Trial locations and contacts
1 site in 1 country.
About this study
Background: In recent years, there has been a rise in the use of immediate loading protocols; however, the complex anatomy of the posterior maxilla presents challenges. Currently, there is a lack of comparative studies assessing the effects of hyaluronic acid and atorvastatin gel on enhancing bone density in this region in conjunction with immediate loading. This study aimed to compare the effect of topical application of atorvastatin gel versus hyaluronic acid around immediately loaded dental implant that replacing missed maxillary posterior teeth.
Patients and methods: twenty one patients were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University seeking implant placement. Patients were divided randomly and equally into three groups: group I (control group): 7 patients received implants without coating by any materials. Group II [Hyaluronic acid (HA) group]: 7 patients received implants coated with HA gel .Group III [atorvastatin (ATV) group]: 7 patients received implants coated with ATV gel. Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative. Also, peri-implant pocket depth (PPD) and modified sulcus bleeding index (mSBI) were evaluated. Radiographical evaluation of bone density (BD) was performed immediately and after 6 months postoperatively of implant loading using CBCT. All clinical and radiographic data were subjected to statistical analysis.
- Conditions
- In Recent Years, There Has Been a Rise in the Use of Immediate Loading Protocols, Dental Implant Stability
- Being tested
- implant surgery
- Keywords
- Immediate loading, Hyaluronic acid, Atorvastatin, ; Bone density; Posterior maxilla.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant surgeryProcedure or surgery
Also called hyaluronic acid around implant, atorvastatin around implant
surgery
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid | Experimental | [Hyaluronic acid (HA) group]: 7 patients received implants coated with HA gel . Receives: Procedure: implant surgery |
| atorvastatin | Experimental | [atorvastatin (ATV) group]: 7 patients received implants coated with ATV gel Receives: Procedure: implant surgery |
| control | Experimental | group I (control group): 7 patients received implants without coating by any materials. Receives: Procedure: implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation
Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative.
Measured: 6 months
clinical evaluation
Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative. Also, peri-implant pocket depth (PPD) and modified sulcus bleeding index (mSBI) were evaluated.
Measured: 6 months
clinical evaluation
peri-implant pocket depth (PPD) around the implant at 3 months and 6 months after loading
Measured: 6 months
Secondary outcomes (2)
radiographic evaluation
Radiographical evaluation of bone density (BD) was performed immediately and after 6 months postoperatively of implant loading using CBCT
Measured: 6 months
clinical evaluation
modified sulcus bleeding index (mSBI) were evaluated at 3 months and 6 months after loading
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 posted16 May 2025
- Study start13 Jul 2023
- Primary completion13 May 2025 (estimated)
- Study completion14 May 2025 (estimated)
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 In Recent Years, There Has Been a Rise in the Use of Immediate Loading ProtocolsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amira attia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira attia, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976866
- Sponsor's protocol ID
- M0103023OS
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Attia AAMM, Eissa SM, Ellayeh M, Marzook HAM. Effect of topical application of atorvastatin gel versus hyaluronic acid on immediate loading dental implant in posterior maxilla: a randomized controlled trial. BMC Oral Health. 2026 Apr 2;26(1):638. doi: 10.1186/s12903-026-08081-4.
PubMed 41928180
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla
- ClinicalTrials.gov ID
- NCT06976866
- Acronym / sponsor ID
- M0103023OS
- Conditions
- In Recent Years, There Has Been a Rise in the Use of Immediate Loading Protocols, Dental Implant Stability
- Keywords
- Immediate loading, Hyaluronic acid, Atorvastatin, ; Bone density; Posterior maxilla.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Amira attiaUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 May 2025 (estimated)
- Study completion
- 14 May 2025 (estimated)
- First posted
- 16 May 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.
Background: In recent years, there has been a rise in the use of immediate loading protocols; however, the complex anatomy of the posterior maxilla presents challenges. Currently, there is a lack of comparative studies assessing the effects of hyaluronic acid and atorvastatin gel on enhancing bone density in this region in conjunction with immediate loading. This study aimed to compare the effect of topical application of atorvastatin gel versus hyaluronic acid around immediately loaded dental implant that replacing missed maxillary posterior teeth.
Patients and methods: twenty one patients were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University seeking implant placement. Patients were divided randomly and equally into three groups: group I (control group): 7 patients received implants without coating by any materials. Group II [Hyaluronic acid (HA) group]: 7 patients received implants coated with HA gel .Group III [atorvastatin (ATV) group]: 7 patients received implants coated with ATV gel. Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative. Also, peri-implant pocket depth (PPD) and modified sulcus bleeding index (mSBI) were evaluated. Radiographical evaluation of bone density (BD) was performed immediately and after 6 months postoperatively of implant loading using CBCT. All clinical and radiographic data were subjected to statistical analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid | Experimental | Procedure: implant surgery[Hyaluronic acid (HA) group]: 7 patients received implants coated with HA gel . |
| atorvastatin | Experimental | Procedure: implant surgery[atorvastatin (ATV) group]: 7 patients received implants coated with ATV gel |
| control | Experimental | Procedure: implant surgerygroup I (control group): 7 patients received implants without coating by any materials. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- -
- patients with one or more missing maxillary posterior teeth
- age ranging from 18 to 45 years
- patient's cooperation
- motivation and good oral hygiene
Key exclusion criteria (5 listed)
- individuals with systemic or local diseases that are contraindicative of surgery or implant placement
- pregnant individuals
- individuals with any bone diseases that may impede bone healing
- smokers
- individuals who exhibit parafunctional habits like bruxism and clenching.
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 |
|---|---|---|
| implant surgeryAlso: hyaluronic acid around implant, atorvastatin around implantsurgery | Procedure or surgery | atorvastatin, control, hyaluronic acid |
Primary outcome
clinical evaluation
Time frame: 6 months
Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative.
clinical evaluation
Time frame: 6 months
Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative. Also, peri-implant pocket depth (PPD) and modified sulcus bleeding index (mSBI) were evaluated.
clinical evaluation
Time frame: 6 months
peri-implant pocket depth (PPD) around the implant at 3 months and 6 months after loading
2 secondary outcomes
radiographic evaluation
Time frame: 6 months
clinical evaluation
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 16 May 2025.
- Derived from this study: PubMed 41928180Attia AAMM, Eissa SM, Ellayeh M, Marzook HAM. Effect of topical application of atorvastatin gel versus hyaluronic acid on immediate loading dental implant in posterior maxilla: a randomized controlled trial. BMC Oral Health. 2026 Apr 2;26(1):638. doi: 10.1186/s12903-026-08081-4.
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 implant surgery in people with In Recent Years, There Has Been a Rise in the Use of Immediate Loading Protocols and Dental Implant Stability, run by Amira attia 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 May 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?
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?
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?
clinical evaluation (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT06976866, 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 16 May 2025.