Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

NCT04151316 | Unknown

• 1 other identifier: BOPT 1 unisr
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prosthetic Tissue Defect; Dental Prosthesis Complication; Dental Prosthesis Failure; Tissue Injury

Outcome Measures

Primary Outcomes (2)

• variation of gingival thickness

  Gingival thickness (GT) measured in millimetres in the mid-buccal area of the tooth, at the central point between the gingival margin and the gingival mucus junction (MGJ) using an endodontic specillus with a silicone stop put in contact with the soft tissue until the specillus reaches the hard surface. At the time of the initial measurement of the periodontal parameters, i.e.

  12 months

• variation of gingival thickness digital

  At the time of the initial measurement of the periodontal parameters, i.e. at the time 0 before the prosthetic preparation of the tooth element, a digital impression is taken in order to obtain a 3D image of the tissues around the tooth element to be rehabilitated.

  The impression is taken before the final impression (t1), at 3 months (t2), 6 months (t3), 12 months (t4) and the 3D images are compared using software to evaluate the variation of the soft tissue.

Secondary Outcomes (7)

• BOP

  TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)

• PPD

  TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)

• Recessions

  TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)

• aesthetic value

  TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)

• patient's satisfaction: VAS scale

  TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive).

Study Arms (2)

vertical group

EXPERIMENTAL

Procedure: crown preparation; Procedure: vertical preparation

horizontal group

EXPERIMENTAL

Procedure: crown preparation; Procedure: horizontal preparation

Interventions

crown preparation PROCEDURE

includes tooth preparation

horizontal group; vertical group

vertical preparation PROCEDURE

type of vertical preparation on the tooth that accepts the crown

vertical group

horizontal preparation PROCEDURE

type of horizontal preparation on the tooth that accepts the crown

horizontal group

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• Absence of active periodontal disease
• over the age of 18;
• periodontal probing less than 4 mm in the tooth to be treated
• absence of bleeding on probing
• full-mouth plaque score (FMPS) and full-mouth bleeding scores (FMBS) \< 20% at the start of the study
• Patients according to protocol participation and informed consent signature.

You may not qualify if:

• contraindication to dental treatment
• active periodontal disease
• systemic diseases that may affect periodontitis
• Pregnant women
• Patients in orthodontic therapy
• inability to return to the controls or to follow oral hygiene maintenance.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Giulia

Milan, Italy/MI, 20123, Italy

Location

Central Study Contacts

Giulia Tetè, DDS

CONTACT

3806479820; tetegiulia92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dental School

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: November 5, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: in a year and a half, we'd produce the data and leave it available.

Locations

IT (1)