Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

NCT ID: NCT04151316

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-11-30

Brief Summary

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When the tooth is severely compromised, it needs a prosthetic crown. The tooth is prepared to allow the housing of the prosthetic crown without difficulty. This study aims to compare two different types of preparations to see with which of the two the gingival tissue reacts best.

Detailed Description

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Conditions

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Prosthetic Tissue Defect Dental Prosthesis Complication Dental Prosthesis Failure Tissue Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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vertical group

Group Type EXPERIMENTAL

crown preparation

Intervention Type PROCEDURE

includes tooth preparation

vertical preparation

Intervention Type PROCEDURE

type of vertical preparation on the tooth that accepts the crown

horizontal group

Group Type EXPERIMENTAL

crown preparation

Intervention Type PROCEDURE

includes tooth preparation

horizontal preparation

Intervention Type PROCEDURE

type of horizontal preparation on the tooth that accepts the crown

Interventions

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crown preparation

includes tooth preparation

Intervention Type PROCEDURE

vertical preparation

type of vertical preparation on the tooth that accepts the crown

Intervention Type PROCEDURE

horizontal preparation

type of horizontal preparation on the tooth that accepts the crown

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Need for restoration by single-tooth prosthetic crown, due to destructive caries, coronal fracture, endodontically treated tooth, severe abrasion, aesthetic problems, remake of old incongruous prosthetic crown, other complications.
2. If there are incongruous conservative restorations (composite fillings or other materials) in the elements adjacent to the tooth to be treated, these must be restored before the prosthetic therapy and must not be modified during the protocol.
3. Absence of active periodontal disease
4. over the age of 18;
5. periodontal probing less than 4 mm in the tooth to be treated
6. absence of bleeding on probing
7. full-mouth plaque score (FMPS) and full-mouth bleeding scores (FMBS) \< 20% at the start of the study
8. Patients according to protocol participation and informed consent signature.

Exclusion Criteria

1. contraindication to dental treatment
2. active periodontal disease
3. systemic diseases that may affect periodontitis
4. Pregnant women
5. Patients in orthodontic therapy
6. inability to return to the controls or to follow oral hygiene maintenance.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Prof. Enrico Gherlone

Head of Dental School

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Giulia

Milan, Italy/MI, Italy

Site Status

Countries

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Italy

Central Contacts

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Giulia Tetè, DDS

Role: CONTACT

3806479820

Facility Contacts

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Giulia Tetè, DDS

Role: primary

3806479820

Other Identifiers

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BOPT 1 unisr

Identifier Type: -

Identifier Source: org_study_id

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