Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System

Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System: Open Ended Prospective Study

Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Usually, the dental implants are inserted and then a period of 3-6 months is waited before any denture is connected to them. Recent studies have demonstrated that connecting the lower denture to the implants immediately after the implant placement, leads to an improvement in the result, with a social and psychological benefit for the patient. Therefore, the aim of this research project is to evaluate the application of the immediate connections of the implants for the upper dentures. 15-40 patients wearing an upper denture will receive 4 dental implants and the denture will be immediately connected. To simplify the surgical procedure, the implants will be placed without exposing the bone. This surgical technique is called guided surgery. Secondary objective of this research project will be the evaluation of the precision of the implant positioning, using this specific technique. The patients will be followed up for 12 months, for the implant and denture evaluation, as well as the evaluation of patient satisfaction and impact on quality of life through questionnaires.

Study Overview

• Status: Active, not recruiting
• Conditions: Denture, Complete; Immediate Dental Implant Loading
• Intervention / Treatment: Device: NOVALOC TiN retained maxillary overdenture

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arif Salman, ABP; Phone Number: 304-293-5831; Email: arifsalman.abdulshakore@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Fully edentulous maxilla
• The implant site has to be healed for at least 4 months after extraction
• Wearing complete dentures deemed adequate
• Orthopantomogram available (OPT)
• Adequate amount of bone at least at the 2nd premolar position to house a 3.75 x 10 mm implant
• No bone grafting required
• Implant IT ≥ 20 N/cm

Exclusion Criteria:

• Conditions requiring chronic routine prophylactic use of antibiotics
• Conditions requiring prolonged use of steroids
• History of leukocyte dysfunction and deficiencies
• Bleeding disorders
• History of neoplastic disease requiring use of radiation or chemotherapy
• Metabolic bone disorders
• Uncontrolled endocrine disorder
• Use of any investigational drug or device within the 30-day period prior to implant surgery
• Smoking more than 10 cigarettes a day
• Alcoholism or drug abuse
• Patient infected with HIV
• Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.

Local exclusion criteria:

• Local inflammation including untreated periodontitis
• Mucosal disease such as erosive lichen planus
• History of local irradiation therapy
• Osseous lesion
• Severe bruxism and clenching habits
• Active infection with suppuration or fistula track
• Persistent intraoral infection
• Lack of primary stability <20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
• Inadequate oral hygiene or unmotivated home care.
• Bone grafting
• Inadequate bone volume for implants insertion as measured on the per-treatment CBCT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NOVALOC TiN; Each subject will receive 4 implants. Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture.	Device: NOVALOC TiN retained maxillary overdenture; 4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic bone level (RBL) change	RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.	Baseline to 6 months post implant
Radiographic bone level (RBL) change	RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.	Baseline to 12 months post implant

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: Institut Straumann AG
• Investigators: Principal Investigator: Arif Salman, BDS, MDSc, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): May 15, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1801929813

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes