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

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.

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Key information

Conditions

Immediate Dental Implant Loading Denture, Complete

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NOVALOC TiN retained maxillary overdenture

Device

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

Primary outcomes

Radiographic Bone Level (RBL) Change

Time frame: Baseline to 6 months post implant

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.
Radiographic Bone Level (RBL) Change

Time frame: Baseline to 12 months post implant

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.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

Institut Straumann AG

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Oct 16, 2023
Registry last updated: Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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