The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement (NABUT)

December 20, 2023 updated by: Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement: 12-months, Parallel, Randomized Clinical Trial

The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement.

The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA.

Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to current literature, physiological bone loss around oral implants is expected after placement and load (1 mm during the first year and 0.2 mm each subsequent year). Different implant designs and surgical protocols have been tested to minimize bone resorption, and subcrestal implant placement partially seems to overcome this issue. However, if this procedure increases the length of the transmucosal tunnel, increasing the risk of peri-implant soft tissue infection.

The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel. The GFA follows the "one abutment one time" concept, which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures. Our objective is to validate or deny this claim.

The study is a monocentric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design. The trial will have a one-year duration, with data collection at the surgical phase, at implant load and 6 and 12 months after load. The primary outcome will be radiographical MBL (marginal bone level) changes around the implant. Secondary outcomes will be the assessment of the peri-implant soft tissues.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • Magda Mensi

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ability to comprehend and sign informed consent.
  • Male and female subjects, aged 18-75 years, inclusive.
  • Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
  • Good oral health (no decay, periapical or periodontal lesions, PI and BOP <25%).

  • Patient with posterior single missing tooth:

    • for at least 5 months,
    • mandibular or maxillary,
    • intercalated (distance between teeth more than 7.5 mm),
    • at least 11 mm of height residual bone (from bone crest to maxillary sinus or inferior alveolar nerve),
    • at least 5 mm of bone width (buccal - palatal/lingual).
  • Availability for the 12-month duration of the study.

Exclusion Criteria:

  • Not willing to follow the agreed protocol.
  • Presence of orthodontic appliances.
  • Smokers more than 10 cigarettes per day.
  • Chronic obstructive pulmonary disease and asthma.
  • Tumors or significant pathology of the soft or hard tissues of the oral cavity.
  • Current radiotherapy or chemotherapy.
  • Pregnant or lactating women.
  • Parafunctions like bruxism.
  • Previous interventions to increase bone thickness in the implant area.
  • Current or past assumption of medications that may influence surgical therapy and/or interfere with healing following surgical treatment.
  • Systemic diseases that constitute a contraindication to surgical therapy and/or interfere with healing following surgical treatment.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcrestal implant and gingival former abutment (GFA)
The subjects receive a subcrestal implant and a prosthodontic device (GFA) immediately during the surgery. The GFA will not be removed upon prosthetic load. It will be an integral part of the prosthetic finalization.
Device: Gingival Former Abutment
GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.
Procedure: Subcrestal Implant
Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.
Device: Prosthetic Crown
A zirconia prosthetic crown finalizes the implant rehabilitation.
Active Comparator: Crestal implant and traditional abutment
The subjects receive a crestal implant and healing abutment. The healing abutment will be replaced by a definitive abutment to the prosthetic load.
Device: Prosthetic Crown
A zirconia prosthetic crown finalizes the implant rehabilitation.
Device: Healing Abutment
A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.
Procedure: Crestal Implant
Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Marginal Bone Level (MBL)
Time Frame: Surgery, 3, 9 and 15 months
The reabsorption of the bone measured through radiographically change on standardised radiographs. Baseline values will be compared to the values recorded in the follow-up visits.
Surgery, 3, 9 and 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PD (periodontal depth) (implant site)
Time Frame: 3, 9 and 15 months
Change in periodontal depth value (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.
3, 9 and 15 months
Change in REC (Clinical Gingival Recession) (implant site)
Time Frame: 3, 9 and 15 months
Change in recession value should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
3, 9 and 15 months
Change in BOP (Bleeding on Probing) (implant site)
Time Frame: 3, 9 and 15 months
Change in percentage of sites positive to bleeding on probing (4 point each situ). Baseline values will be compared to the values recorded in the follow-up visits.
3, 9 and 15 months
Change in PI (Plaque Index) (implant site)
Time Frame: 3, 9 and 15 months
Change in percentage of site with plaque (4 point each situ). Baseline values will be compared to the values recorded in the follow-up visits.
3, 9 and 15 months

Collaborators and Investigators

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

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Magda Mensi, ASST Spedali Civili di Brescia

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 6, 2021

Primary Completion (Actual)

June 7, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABUT NP 4078

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.

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