Outcome of Implant-supported Overdentures

March 10, 2020 updated by: RWTH Aachen University

A Pilot Study to Clinically Evaluate Maxillary and Mandibular Overdentures Retained by Two Unsplinted Diameter-reduced Titanium-zirconium Implants

The aim of this pilot study was to assess survival rates and peri-implant bone loss of two narrow-diameter titanium-zirconium implants supporting maxillary and mandibular overdentures during an observation time of 3 years. The masticatory performance, self-reported chewing ability and change of oral health impact profile (OHIP) after rehabilitation were also investigated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to the recent German Oral Health Study (DMS V), toothlessness is still frequently represented in the German population. Thus in the group of 65 to 74 years old 12.4% were edentulous. Whereas in the group of 75 to 100 years old 32.8% were toothless. Toothlessness occurred more frequently in the upper jaw (19,8%) than in the lower jaw (13,7%).

Although maxillary complete dentures show less retention problems than mandibular complete dentures, edentulous patients often wish prosthesis without a palatal coverage. Since the palate is not covered by the prosthesis, the taste sense will not be affected. Zembic et al. show a significantly higher patient satisfaction for esthetics (mean difference 8.8 mm ± 24.6) and taste (mean difference 28.4 mm ± 29.9) without palatal coverage. To prevent a palatal coverage at least four implants in the upper jaw are recommended.

A systematic review concluded that implant loss rates for maxillary overdentures on two implants were significantly higher than for four implants. The recommendation to place more than two implants in the edentulous maxilla is also based on the results of a study by Richter and Knapp. Richter et al. detected very low survival rates for two implants and various anchoring elements in the edentulous upper jaw after mean observation time of five years. The 15 patients received diameter-reduced (3.25 mm) implants in the canine area. The implants were not parallel to each other due to anatomical limitations. The prostheses were attached either with telescopes or locator attachments. The implant survival rate was 39% for telescope attachments and 14% for locator attachments. The study resulted in high amount of implant fractures. In contrast, a recent study of Zembic et al. concluded an implant survival rate of 97.3% (1 year), for maxillary overdentures supported by 2 titanium-zirconium implants.

However, the systematic review and meta-Analysis from Di Francesco et al. also verifies the lack of evidence concerning the number of implants in the edentulous maxilla and the relationship between overdenture survival and the patient's quality of life.

In the planned observation study, the investigators also used diameter-reduced (3.3 mm) implants. Similarly in the study before the investigators selected a titanium-zirconium (TiZr) implant called Roxolid® (Straumann) to prevent high rate of implant fracture. According to several previous studies the TiZr small-diameter bone level implants provide at least the same outcomes after 12 month as titanium Grade IV bone level implants. The implant survival and success rates were 100% for TiZr implants.These promising results were first indications for an improved mechanical property of TiZr implants which may extend implant therapy to more challenging clinical situations, as discussed before for edentulous maxilla.

In addition, the investigators use a new anchoring system called CM LOC® and CM LOC Flex® to compensate different implant angulation. CM LOC Flex® anchor system offers the special advantage of a broad range of clinical applications due to its unique compensation function. The abutment can be angled up to 60°, which significantly reduce the wear between female part and titanium patrix. There is already an in vitro study by Passia et al., demonstrating positive long-term retention behaviour for CM LOC® in comparison to Locator anchor.

In the actual study the investigators included ten maxillary and mandible edentulous patients (58-79 years old) being dissatisfied with their complete dentures. In total, 40 diameter-reduced titanium-zirconium implants were placed in the canine region of the upper and lower jaw. Following 3 to 5 months of healing, implant-supported overdentures were inserted on two CM LOC® and CM LOC Flex® attachments depending on the indication. Implants and overdentures were evaluated at 4 weeks (baseline) and 6, 12, 24, 36 months after insertion of overdentures. Standardized radiographs were taken at implant loading and 12, 36 month after loading. Implant survival rates and bone loss were the primary outcomes.

The oral health related quality of life was assessed before and after treatment by means of the questionnaires OHIP G14. Further, each patient completed an additional questionnaire to evaluate chewing satisfaction for soft and hard foods. Questions were answered on a 100-mm visual analogue scale (VAS). Additionally, the masticatory performance was assessed with a standardized chewing test. The participants were instructed to chew standardised gums with three degrees of hardness for 30 seconds, each on the right and left side as well as on both sides. The chewed particles were then spread to a standardized detection sheet. Each sheet is placed in a tripod, and photos were made. Chewing efficacy was obtained before treatment, at baseline, 6, 12, 24, 36 month after implant loading.

Descriptive statistics were applied by calculating means, medians, standard deviations, and interquartile ranges of bone loss and of the questionnaires. Bone loss and the questionnares were statistically assessed using the Wilcoxon signed rank test. The level of significance was set at 5%.

The evaluation of the standardized masticatory function test was performed automatically through the use of a light sensor that measures the size and amounts of chewed particles.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female and male subjects older than 18 years.
  • Edentulous patients with a bone atrophy, which necessitates the use of diameter-reduced implants and excessive augmentation procedures are denied by the patient.
  • Sufficient bone supply with minimal risk of injury to neighboring structures when using two 10 mm or longer implants per jaw.
  • Bone height above the N. alveolaris inferior of at least 11 mm and the precondition of a one-stage implantation and augmentation.
  • Good health condition according to the Physical Status Classification System one or two (American Society of Anesthesiologists, ASA 2010)
  • Good oral hygiene and an at most moderate tobacco consumption
  • Signed informed consent

Exclusion Criteria:

  • Indication for large augmentations of the jaw bone
  • Allergy to metallic implant components or prosthesis plastics
  • Bisphosphonate therapy
  • Chemo-, immuno-, or radiation therapy
  • Psychological disorder
  • Substance abuse
  • Pregnant woman
  • Persons who are placed in an institution on a judicial or administrative order
  • Any other circumstances that prevent the use of oral surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Two dental implants in the edentulous maxilla and mandible
Edentulous maxilla und mandible are treated with two diameter-reduced tissue level implants (Straumann, Basel) and anchored with CM LOC® and CM LOC Flex® attachments (Cendres+Métaux SA, Bienne).
Device: dental implants and stud attachments
Other Names:
  • CM LOC® and CM LOC Flex® (Cendres+Métaux SA, Bienne)
  • (sandblasted/acid-etched) SLActive® Roxolid® implants, Ø 3.3 mm (Straumann, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigation of the success rates of the implants
Time Frame: 5 Years
Implant fracture, implant loss
5 Years
Marginal bone loss
Time Frame: 5 years
Measurement of marginal bone loss on standardized radiographs [mm]
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 5 Years
Measurement of probing depth [mm]
5 Years
Gingival status
Time Frame: 5 Years
Assessment of gingival index
5 Years
Oral hygiene
Time Frame: 5 Years
Assessment of plaque index
5 Years
Oral Health Quality of Life
Time Frame: 5 years
Oral Health Impact Profile - G14 (OHIP-G14, short version of the OHIP with 14 questions, according to Slade). Responses are made on a scale of never (0), hardly (1), occasionally (2), fairly often (3) and very often (4), resulting in possible values from 0 to 56 points in total.
5 years
Chewing satisfaction
Time Frame: 5 years
Assessment of the chewing satisfaction using a Visual Analogue Scale (VAS). The beginning of the scale is defined as "completely dissatisfied" and the end of the line as "completely satisfied".
5 years
Masticatory performance
Time Frame: 5 years
Assessment of the masticatory performance with a standardized chewing test. The participants are instructed to chew standardised gums with three degrees of hardness for 30 seconds each on the right and left sides as well as on both sides. The chewed particles were then spread to a standardized detection sheet. Each sheet is placed in a standardized stand support and are photographed.
5 years
Survival rate of prosthetic restoration
Time Frame: 5 years
The prosthesis is examined for cracks, fractures, discolorations or other defects. Pass accuracy is examined. Visual and tactile control of the CM LOC® abutments and of the matrices (with retention inserts) are done.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Institut Straumann AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (ACTUAL)

December 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKA 373147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe