Clinical trial NCT06334770: Influence of Roxolid Implant Material on the Implant Stability Implant Stability
Official title: Influence of Roxolid Implant Material on the Implant Stability of Maxillary Implant Retained Overdenture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Completely Edentulous Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.

After fabrication of complete denture for all patients, patients were randomly divided to:

Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.

Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.

After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.

After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.

Patients were recalled frequently for post-insertion inspection and adjustment.

Detailed description: Background: long term success of implant restoration depends on many factors one of them is the sufficient implant stability which is lowered in compromised bone density sites such as the maxilla which is categorized as type III \& IV bone, so searching for new innovation and updates in implant material and features is very mandatory. So, the aim of this study was asses and compare between two implant materials roxolid versus traditional titanium on the primary and secondary stability.

Methods: eighteen completely edentulous patients were selected they all received maxillary implant retained overdentures and lower complete dentures, they were divided equally in to two groups according to the type of the material of the implants. Group A received a total number of 36 (Roxolid) Implants were made of roxolid material and Group B received a total number 36 (Titanium) implants were made of traditional titanium alloys. Implant stability was assed using ostell device, the primary implant stability was measured at the day of implant installation however, secondary implant stability was measured after six weeks of implant placement. Paired t-test was used to compare between primary and secondary stability in the same group and independent t-test was used to compare between the two groups with a significant level \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients as the last extraction should be at least six months before implant placement.

  * Patients with good oral hygiene.
  * Sufficient inter arch space (11 mm) which were diagnosed by mounted diagnostic casts.
  * Firm and healthy mucosa covering the residual alveolar ridge.

Exclusion Criteria:

* - Heavy smokers.
* Patients with para functional habits.
* Patients had TMJ disorders.
* Patients had systemic disease that could interfere with implant placement or affect bone healing such as; thyroid and uncontrolled diabetes.
* Patients undergoing chemo and radiotherapy.

Primary outcomes:
measure: measuring primary at time of surgery
timeFrame: same day of implant placement
Secondary outcomes:
measure: secondary implant stability after 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry of Dentistry Ainshams Univeristy
Study officials:
affiliation: Ains hams univeristy
name: shaimaa L mohamed, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022.
citation: Thanasrisuebwong P, Pimkhaokham A, Jirajariyavej B, Bencharit S. Influence of the Residual Ridge Widths and Implant Thread Designs on Implant Positioning Using Static Implant Guided Surgery. J Prosthodont. 2023 Apr;32(4):340-346. doi: 10.1111/jopr.13557. Epub 2022 Jun 22.