Surface Treatment of the Dental Implant on the Osseointegration

• Sponsor: Hams Hamed Abdelrahman (Other)
• Overall Status: Completed
• CT.gov ID: NCT05194813
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.4
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implants; Surface Treatment	Other: Aqua alvim CM, neodent implant (Test); Other: Neoporous alvim CM, neodent implant (Control)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Surface Treatment of the Dental Implant on the Osseointegration in Mandibular Posterior Missing Teeth
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Jun 15, 2021
• Actual Study Completion Date: Jun 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in implant stability [at baseline and 6 months]

   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

2. Change in bone density [at baseline and 6 months]

   Cone beam Computerized tomography was used to assess bone denisty

3. Change in ridge height [at baseline and 6 months]

   Cone beam Computerized tomography was used to assess ridge height

4. Biochemical assessment of bone formation [at 3 months]

   Done by measuring of Runt-related transcription factor 2 (RUNX2) as a bone marker by Enzyme-Linked Immunosorbent Assay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

• Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT05194813
• Other Study ID Numbers: Implants2022
• First Posted: Jan 18, 2022
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 18, 2022