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Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

U

Università Vita-Salute San Raffaele

Status

Unknown

Conditions

Prosthetic Tissue Defect
Tissue Injury
Dental Prosthesis Failure
Dental Prosthesis Complication

Treatments

Procedure: crown preparation
Procedure: horizontal preparation
Procedure: vertical preparation

Study type

Interventional

Funder types

Other

Identifiers

NCT04151316
BOPT 1 unisr

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

vertical group
Experimental group
Treatment:
Procedure: crown preparation
Procedure: vertical preparation
horizontal group
Experimental group
Treatment:
Procedure: crown preparation
Procedure: horizontal preparation

Trial contacts and locations

1

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Central trial contact

Giulia Tetè, DDS

Data sourced from clinicaltrials.gov

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