Back to resultsAssessment of Novaloc and Locator Attachment Systems
Primary Purpose
Completely Edentulous Maxilla
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Novaloc attachment
Locator attachment
Sponsored by
About this trial
This is an interventional treatment trial for Completely Edentulous Maxilla focused on measuring implant overdenture, maxilla, novaloc, locator, peek
Eligibility Criteria
Inclusion Criteria: Completely edentulous patient with u shaped dental arch. Systemically free. Patients completed all extraction at least 6 months before surgery. Patients Tempromandibular joint is free from any disease. Patient's mouth opening is proper for accessibility during surgery and implant placement. Sufficient bone level (length, and width) at implant placement site. Presence of enough bone height at implant site close to the maxillary sinus. Absence of sinus pneumatization. Exclusion Criteria: Heavy smoker. Patients with bone diseases. Patients having a history of parafunctional habits. Patients with diabetes mellitus. Patients on chemotherapy or radiotherapy. Patients on any medications that reduce wound healing. Patients without sufficient bone level (height, width). Patients with sinus pneumatization.
Sites / Locations
- Prosthodontics Department Faculty of Dentistry Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Novaloc attachment
locator attachment
Arm Description
a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon.
a device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees
Outcomes
Primary Outcome Measures
bone level change around implants
measurement of bone height mesial, distal to each implant
Secondary Outcome Measures
patient satisfaction
Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06011031
Brief Title
Assessment of Novaloc and Locator Attachment Systems
Official Title
Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
December 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct.
Detailed Description
14 Completely edentulous patients will be divided into two groups each group contains seven patients: Group One: Each patient will be restored with 4 implant retained maxillary overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.
Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using Nylon retention insert attachment system and Bone Level Ti implants.
Bone height in millimeters will then be evaluated around each implant using cone beam computed tomography at the time of placement of attachments, 6 months, 1 year
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Completely Edentulous Maxilla
Keywords
implant overdenture, maxilla, novaloc, locator, peek
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a Randomized Clinical Trial (phase IV) as it will compare two types of attachment systems (a new one with an old one), assess the effects of both types, and state which one is better.
Masking
Investigator
Masking Description
all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Novaloc attachment
Arm Type
Experimental
Arm Description
a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon.
Arm Title
locator attachment
Arm Type
Active Comparator
Arm Description
a device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees
Intervention Type
Device
Intervention Name(s)
Novaloc attachment
Intervention Description
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
Intervention Type
Device
Intervention Name(s)
Locator attachment
Intervention Description
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
Primary Outcome Measure Information:
Title
bone level change around implants
Description
measurement of bone height mesial, distal to each implant
Time Frame
Through study completion an average 1 year.
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction.
Time Frame
Through study completion an average 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Completely edentulous patient with u shaped dental arch.
Systemically free.
Patients completed all extraction at least 6 months before surgery.
Patients Tempromandibular joint is free from any disease.
Patient's mouth opening is proper for accessibility during surgery and implant placement.
Sufficient bone level (length, and width) at implant placement site.
Presence of enough bone height at implant site close to the maxillary sinus.
Absence of sinus pneumatization.
Exclusion Criteria:
Heavy smoker.
Patients with bone diseases.
Patients having a history of parafunctional habits.
Patients with diabetes mellitus.
Patients on chemotherapy or radiotherapy.
Patients on any medications that reduce wound healing.
Patients without sufficient bone level (height, width).
Patients with sinus pneumatization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Ibrahim Eid, Prof
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noha Helmy Nawwar, Prof
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Osama, Prof
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatma Fouad Sadek, AssistantLec
Organizational Affiliation
Egyptian Russian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prosthodontics Department Faculty of Dentistry Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done
IPD Sharing Time Frame
1 year following publishing
IPD Sharing Access Criteria
researchers , students or post graduates
Learn more about this trial
Assessment of Novaloc and Locator Attachment Systems
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