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

NCT06976866 | Active Not Recruiting DMC

• 1 other identifier: M0103023OS
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Immediate loading; Hyaluronic acid; Atorvastatin; ; Bone density; Posterior maxilla.

Outcome Measures

Primary Outcomes (3)

• clinical evaluation

  Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative.

  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.

  6 months

• clinical evaluation

  peri-implant pocket depth (PPD) around the implant at 3 months and 6 months after loading

  6 months

Secondary Outcomes (2)

• radiographic evaluation

  6 months

• clinical evaluation

  6 months

Study Arms (3)

hyaluronic acid

EXPERIMENTAL

\[Hyaluronic acid (HA) group\]: 7 patients received implants coated with HA gel .

Procedure: implant surgery

atorvastatin

EXPERIMENTAL

\[atorvastatin (ATV) group\]: 7 patients received implants coated with ATV gel

Procedure: implant surgery

control

EXPERIMENTAL

group I (control group): 7 patients received implants without coating by any materials.

Procedure: implant surgery

Interventions

implant surgery PROCEDURE

surgery

Also known as: hyaluronic acid around implant, atorvastatin around implant

atorvastatin; control; hyaluronic acid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amira attia: lead

Study Sites (1)

Amira Attia

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 16, 2025
• Study Start: July 13, 2023
• Primary Completion: May 13, 2025
• Study Completion: May 14, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

EG (1)