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

NCT06083506 | Completed Results FDA Device

• 1 other identifier: 1801929813
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immediate Dental Implant Loading; Denture, Complete

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

NOVALOC TiN

OTHER

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

Interventions

NOVALOC TiN retained maxillary overdenture DEVICE

4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture

NOVALOC TiN

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 inflammation including untreated periodontitis
• Mucosal disease such as erosive lichen planus
• History of local irradiation therapy

Sponsors & Collaborators

• West Virginia University: lead
• Institut Straumann AG: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Results Point of Contact

• Title: Arif Salman Abdul Shakore
• Organization: WestVirginiaU

arifsalman.abdulshakore@hsc.wvu.edu

304-293-5831

Study Officials

• Arif Salman, BDS, MDSc

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 16, 2023
• Study Start: January 3, 2019
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Locations

US (1)