Insertion Protocol of Convergent Transmucosal Design Implants

February 14, 2024 updated by: Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari

Clinical and Radiographic Evaluation of Equicrestal and Subcrestal Positioning of a Tissue Level Implant With Convergent Transmucosal Profile - Randomized Clinical Trial

The aim of this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest level).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary outcomes will be the measurement of the marginal bone level (MBL) at various time intervals and the evaluation of the soft tissues according to a score defined as Pink Esthetic Score (PES). Secondary outcomes will be plaque index (PI); the bleeding index (BI), biological complications (peri-implant mucositis, peri-implantitis, abscesses), implant failure, prosthetic complications (chipping, fractures) and prosthetic failure.

The subjects recruited for the study will be those belonging to the oral surgery department of the San Giovanni di Dio Hospital in Cagliari.

Each patient will receive only one implant or, in any case, only one implant per patient will be included in the analysis. A random sequence will be generated via Randomization.com, useful for assigning patients into the equicrestal and subcrestal implant placement groups.

All patients will undergo the same preoperative, intraoperative and postoperative procedures.

Preoperative procedures An intraoral radiograph of the edentulous site will be performed. Upper and lower alginate impressions will be made on each patient for planning and fabrication of surgical guides, all patients will receive rigorous oral hygiene and instructions will be provided to improve and maintain home oral hygiene.

Intraoperative procedures After local anesthesia of the site to be operated on, a full thickness mucoperiosteal flap will be elevated, after lifting the flap the implant site will be prepared according to the manufacturer's protocol. Before implant placement, the sealed envelope will be opened for random assignment of the patient to one of the two groups. The implant will therefore be positioned, depending on the assignment group, in an equicrestal or subcrestal position, in the latter case a further step with the last preparation drill will be performed to deepen the site.

The flap will be sutured after placement of the healing screw and specific hygiene instructions for the healing site will be given to the patient. The appropriate analgesic and antibiotic therapy will be prescribed.

An intraoral x-ray will be performed in a standardized and repeatable manner to assess bone levels.

The patient will be followed following the following follow-up scheme, reserving the right to recall the patients involved even at longer time intervals to evaluate the aforementioned outcomes also in the medium (24 months) and long (5-10 years) term.

  1. week: healing check
  2. weeks: healing check and suture removal

1 month: healing check 3 months: prosthesis and intraoral x-ray, measurement of soft tissue parameters via PES after positioning of the prosthetic crown 6 months: intraoral x-ray and PES 12 months: intraoral x-ray and PES The marginal bone level will be measured using ImageJ software (NIH freeware) on the distal and mesial aspects of each implant at each time point where it is foreseen.

Study Type

Interventional

Enrollment (Estimated)

25

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 Contact

Study Locations

  • Italy
    • CA
      • Monserrato, CA, Italy, 09042
        • Recruiting
        • Policlinico Duilio Casula, AOU Cagliari
        • Contact:
        • Principal Investigator:
          • Nicola Alberto Valente, DDS, MS, PHD

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:

  • Age >18 years
  • Absence of periodontal disease
  • Full mouth plaque score and full mouth bleeding score less than or equal to 25%
  • Sufficient bone height and width to place an implant in a prosthetically guided position without performing bone grafting procedures
  • Stable occlusion

Exclusion Criteria:

  • Smokers (more than 10 cigarettes a day)
  • Medical conditions that contraindicate implant surgery
  • Pregnant and breastfeeding patients
  • Patients with a history of therapy with bisphosphonates or biologics
  • Patients undergoing chemotherapy or radiation therapy of the head and neck
  • Decompensated diabetes
  • Severe bruxism
  • Poor oral hygiene or uncooperative patients (incomplete data collection or failure to attend scheduled check-up appointments)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sub-crestal
Implants will be placed 1mm under the bone crest level
Procedure: Sub-crestal Implant placement
A site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is 1mm below the level of the bone crest.
Active Comparator: Equi-crestal
Implants will be placed at the bone crest level
Procedure: Equi-crestal Implant placement
A site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is exactly at the same level as the bone of the maxillary/mandibular edentulous crest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant mucosa health and condition in terms of Plaque Index (PI).
Time Frame: 6-12 months
The Plaque Index (PI) will be calculated. A value of 0 will be assigned if supragingival plaque is not visible, a value of 1 if visible.
6-12 months
Peri-implant mucosa health and condition in terms of Bleeding Index (BI)
Time Frame: 6-12 months
The Bleeding Index will be calculated on the sites where the periodontal probing will be carried out, a procedure for measuring the depth of the gingival sulcus on 6 sites per tooth (mesial, central, distal, both vestibular and lingual) with a periodontal probe. A value of 0 will be given if there is no bleeding and 1 if the site bleeds within 30 seconds
6-12 months
Peri-implant bone health and condition in terms of change in marginal bone level (MBL)
Time Frame: 6-12 months
The bone around the implant will be radiographically evaluated in terms of possible resorption measured, using ImageJ software (NIH freeware), on the distal and mesial aspect of each implant at each time point where it is foreseen.
6-12 months
Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES).
Time Frame: 6-12 months
The PES (Pink Esthetic Score) is a score that evaluates the appearance of the peri-implant soft tissues which examines various parameters giving a value from 0 (worst) to 2 (best) each. (1. the presence/absence of the interproximal papilla both mesial and distal (0=absent, 2=complete); 2. the festooning of the gingival margin in correspondence with the implant (0=unnatural, 2=natural); 3. the position of the gingival margin (0=major discrepancy from reference tooth, 2=no discrepancy); 4. the color of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 5. the appearance (texture) of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 6. defects of the alveolar process (0=obvious deficiency, 2=no deficiency)).
6-12 months

Collaborators and Investigators

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

Sponsor

University of Cagliari

Investigators

  • Principal Investigator: Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari

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)

February 14, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PramaNAV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Implant Site Reaction

Clinical Trials on Sub-crestal Implant placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe