Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla

May 9, 2025 updated by: Amira attia

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Amira Attia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-

Inclusion criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hyaluronic acid
[Hyaluronic acid (HA) group]: 7 patients received implants coated with HA gel .
Procedure: implant surgery
surgery
Other Names:
  • hyaluronic acid around implant
  • atorvastatin around implant
Experimental: atorvastatin
[atorvastatin (ATV) group]: 7 patients received implants coated with ATV gel
Procedure: implant surgery
surgery
Other Names:
  • hyaluronic acid around implant
  • atorvastatin around implant
Experimental: control
group I (control group): 7 patients received implants without coating by any materials.
Procedure: implant surgery
surgery
Other Names:
  • hyaluronic acid around implant
  • atorvastatin around implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
clinical evaluation
Time Frame: 6 months
peri-implant pocket depth (PPD) around the implant at 3 months and 6 months after loading
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic evaluation
Time Frame: 6 months
Radiographical evaluation of bone density (BD) was performed immediately and after 6 months postoperatively of implant loading using CBCT
6 months
clinical evaluation
Time Frame: 6 months
modified sulcus bleeding index (mSBI) were evaluated at 3 months and 6 months after loading
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amira attia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2023

Primary Completion (Estimated)

May 13, 2025

Study Completion (Estimated)

May 14, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

May 9, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M0103023OS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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