Surface Treatment of the Dental Implant on the Osseointegration

The Effect of Surface Treatment of the Dental Implant on the Osseointegration in Mandibular Posterior Missing Teeth

Dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. In order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have undergone continuous improvement to improve the function and longevity of the implants. Recently the constant search for improvements in modern implant have been focused on surface modifications so a new era of surface treatment have been showed up; the chemically modified hydrophilic surfaces.

Study Overview

• Status: Completed
• Conditions: Dental Implants; Surface Treatment
• Intervention / Treatment: Other: Aqua alvim CM, neodent implant (Test); Other: Neoporous alvim CM, neodent implant (Control)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Missing mandibular posterior teeth.
• Good oral hygiene (plaque index less than 10 %)
• Good compliance to the treatment.
• Participants are free from local or systemic disease
• Willingness and ability to commit to follow-up placement.
• Adequate bone height and width to accommodate implant placement and sufficient keratinzed mucosa.
• At least 3months after tooth extraction
• Sufficient interocclusal distance

Exclusion criteria

• Presence of persistent and unresolved infection in the implant site
• Parafunctional habits.
• Heavy Smokers.
• Uncontrolled systemic disease that impedes bone healing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hydrophilic sandblasted and acid-etched dental implants	Other: Aqua alvim CM, neodent implant (Test); Acqua, Hydrophilic sandblasted, and acid-etched dental implants
ACTIVE_COMPARATOR: Conventional hydrophobic sandblasted and acid-etched dental implant	Other: Neoporous alvim CM, neodent implant (Control); Neoporous, Hydrophilic sandblasted, and acid-etched dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant stability	The implant stability measurement was examined at the time of insertion of the implants (primary stability) and 6 months (secondary stability) for the two groups of patients using the resonance Frequency Analysis (RFA) via the Osstell ISQ system	at baseline and 6 months
Change in bone density	Cone beam Computerized tomography was used to assess bone denisty	at baseline and 6 months
Change in ridge height	Cone beam Computerized tomography was used to assess ridge height	at baseline and 6 months
Biochemical assessment of bone formation	Done by measuring of Runt-related transcription factor 2 (RUNX2) as a bone marker by Enzyme-Linked Immunosorbent Assay	at 3 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (ACTUAL): January 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Implants2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No