Clinical trial NCT06976866: Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla
Official title: Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

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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.

Primary outcomes:
measure: clinical evaluation
timeFrame: 6 months
measure: clinical evaluation
timeFrame: 6 months
measure: clinical evaluation
timeFrame: 6 months
Secondary outcomes:
measure: radiographic evaluation
timeFrame: 6 months
measure: clinical evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Amira Attia
Study officials:
References: