Surface Treatment of the Dental Implant on the Osseointegration

NCT05194813 | Completed

• 1 other identifier: Implants2022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants; Surface Treatment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Hydrophilic sandblasted and acid-etched dental implants

EXPERIMENTAL

Other: Aqua alvim CM, neodent implant (Test)

Conventional hydrophobic sandblasted and acid-etched dental implant

ACTIVE COMPARATOR

Other: Neoporous alvim CM, neodent implant (Control)

Interventions

Aqua alvim CM, neodent implant (Test) OTHER

Acqua, Hydrophilic sandblasted, and acid-etched dental implants

Hydrophilic sandblasted and acid-etched dental implants

Neoporous alvim CM, neodent implant (Control) OTHER

Neoporous, Hydrophilic sandblasted, and acid-etched dental implants

Conventional hydrophobic sandblasted and acid-etched dental implant

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: November 1, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

EG (1)