Insertion Protocol of Convergent Transmucosal Design Implants

NCT06254885 | Recruiting

• 1 other identifier: PramaNAV
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Implant Site Reaction

Keywords

Peri-implant mucosa; Peri-implant bone; Transmucosal profile

Outcome Measures

Primary Outcomes (4)

• Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES).

  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

• Peri-implant mucosa health and condition in terms of Plaque Index (PI).

  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)

  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)

  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

Study Arms (2)

Sub-crestal

EXPERIMENTAL

Implants will be placed 1mm under the bone crest level

Procedure: Sub-crestal Implant placement

Equi-crestal

ACTIVE COMPARATOR

Implants will be placed at the bone crest level

Procedure: Equi-crestal Implant placement

Interventions

Equi-crestal Implant placement PROCEDURE

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.

Equi-crestal

Sub-crestal Implant placement PROCEDURE

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.

Sub-crestal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Policlinico Duilio Casula, AOU Cagliari

Monserrato, CA, 09042, Italy

RECRUITING

Study Officials

• Nicola Alberto Valente, DDS, MS, PhD

  University of Cagliari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Alberto Valente, DDS, MS, PhD

CONTACT

+393385932069; nicola.valente@unica.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 12, 2024
• Study Start: February 14, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

IT (1)