Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants

NCT06081192 | Unknown

• 1 other identifier: PI07294-2023
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, single-group, prospective clinical trial testing a partially-guided protocol for placement of mini implants overdentures in the edentulous maxilla. Eligible participants will be subjects with an edentulous maxilla, wearing a conventional complete denture. Participants will receive six mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) for retention of a maxillary overdenture. The six mini implant protocol will be virtually planned for an even distribution of the implants bilaterally, with a minimum of 5 mm distance between contiguous implants. The available lengths of the mini implants are 10, 12, and 14 mm, and the appropriate length will be selected according to the bony anatomical situation. In addition, the distribution and axial position of the mini implants will be planned to achieve the best biomechanical distribution and the most parallel position between implants, perpendicular to the occlusal plane and path of insertion of the prosthesis. The primary outcome will be the accuracy of the implant position using the partially-guided protocol. Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). Additional outcomes will include implant survival and success rates, incidence of prosthodontic complications and peri-implant measurements.

Conditions

Edentulous Jaw; Implant Complication

Keywords

Dental implant; Overdenture; Edentulous patient; Clinical study; Effectiveness

Outcome Measures

Primary Outcomes (9)

• Accuracy of implant placement

  Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. The global deviation is defined as the 3D distance between the coronal/apical centers of the planned and placed implants. The vertical deviation is the distance between the coronal center of the longitudinal axis of the planned implant and a plane parallel through the coronal center of the placed implant. The angle deviation will be measured as the angular divergence between the longitudinal axes of the planned and actual position of the mini implants. The divergence of the implant axis (in degrees) will also be recorded.

  6 weeks

• Surgery intercurrencies and complications

  Any complications associated with the surgical procedures, or deviations from the prescribed protocol due to surgical intercurrences will be recorded. These include failed drilling of the planned implant site, need to raise a flap for adequate positioning of the needle drill, fracture of the bone walls, insufficient insertion torque (\< 10 Ncm), early implant failure, and others.

  6 weeks

• Treatment intercurrencies and complications

  Any post-treatment complications associated with the use of the maxillary overdenture

  Through study completion, an average of 1 year

• Oral health-related quality of life impacts

  Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). It contains 19 questions in seven domains and proved to be sensitive to changes in prosthetic treatment and oral health. For each of the questions, subjects are asked how frequently they have experienced the event during the last month. Responses are given on a 5-item Likert scale. In this study, the validated Portuguese translation of the questionnaire will be utilized.

  6 months

• Oral health-related quality of life impacts

  Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). It contains 19 questions in seven domains and proved to be sensitive to changes in prosthetic treatment and oral health. For each of the questions, subjects are asked how frequently they have experienced the event during the last month. Responses are given on a 5-item Likert scale. In this study, the validated Portuguese translation of the questionnaire will be utilized.

  1 year

• Denture Satisfaction Index

  Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI; (25)), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition.

  6 months

• Denture Satisfaction Index

  Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI; (25)), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition.

  1 year

• Implant Survival and Success

  Implant Survival and Success rate will be defined as followed: I - Success (optimum health) II - Satisfactory survival III - Compromised survival IV - Failure (clinical absolute failure) Any of following Additionally, fractured implants will be considered as failures, except fracture of the implant apex during implant placement. Any dental implant showing excessive bone loss, such as radiolucency or infection, shall be treated in the manner best suited to the well-being of the subject, including treatment to save the dental implant.

  Through study completion, an average of 1 year

• Prosthetic Success and Survival

  One of the following: * Patrix fracture * Dislodged, worn or loose matrix housing * Matrix replacement * Matrix fracture * Fracture of the implant-supported overdenture * Fracture of the acrylic above a patrix * Fracture of denture teeth * Relining of implant overdenture A failure will be defined as an event leading to the loss of the reconstruction and need for the fabrication of a new overdenture.

  Through study completion, an average of 1 year

Secondary Outcomes (12)

• Chewing efficiency

  1-year

• Maximum voluntary bite force (MBF)

  1-year

• Plaque index

  1-year

• Bleeding on probing

  1-year

• Pocket probing depth

  1-year

Study Arms (1)

One-piece titanium-zirconium mini implants

EXPERIMENTAL

Six one-piece titanium-zirconium mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) in the edentulous maxilla, using a partially-guided insertion protocol.

Procedure: Implant placement surgery

Interventions

Implant placement surgery PROCEDURE

Placement of six mini implants in the edentulous maxilla using a partially-guided protocol

Also known as: Dental implant

One-piece titanium-zirconium mini implants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 60 years of age
• healed dentulous maxillary arch (minimum of twelve weeks since the last extraction)
• wearing a complete maxillary denture evaluated as sufficient for surgical planning
• minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area
• bone dimensions allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm.
• general health condition should be a physical status ASA1 or ASA2.

You may not qualify if:

• inability to perform adequate oral hygiene
• incapability to provide written informed consent and compliance to the protocol
• any contraindication for oral surgery such as but not limited to,
• uncontrolled diabetes
• immunosuppression
• radiation or chemotherapy
• antiresorptive medication such as bisphosphonates
• presence of dental, periodontal or peri-implant disease in the opposing arch
• presence of a conventional complete denture in the opposing arch (mandible)
• presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline
• heavy smoking habit with \> 20 cig/d
• reported severe bruxism or clenching habits
• clinically present oro-facial pain
• depression with a Geriatric Depression Scale above 12
• xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• ITI International Team for Implantology, Switzerland: collaborator
• Institut Straumann AG: collaborator

Related Publications (29)

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MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Cláudio R Leles, PhD

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cláudio R Leles, PhD

CONTACT

+5562981113302; claudio_leles@ufg.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applied
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Single-center, single-group, prospective clinical trial

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share