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Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

Primary Purpose

Prosthetic Tissue Defect, Dental Prosthesis Complication, Dental Prosthesis Failure

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
crown preparation
vertical preparation
horizontal preparation
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prosthetic Tissue Defect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Giulia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

vertical group

horizontal group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

BOP
percentage of bleeding of the gingival sulcus of all dental elements using a millimeter periodontal probe
PPD
probing depth (PD), recorded in millimetres at 6 points for each tooth using a millimeter periodontal probe
Recessions
relative gingival recession (rREC), measured at 6 points for each tooth as the distance from the gingival margin (GM) to the apical edge of the acrylic template previously using a millimeter periodontal probe
aesthetic value
Aesthetic evaluation of soft tissue is performed with the Pink Aesthetic Score/White Aesthetic Score (PES/WES). The PES evaluation consists of 7 variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue texture and color. Mucosa is evaluated with WES, which consists of 5 variables: tooth shape, volume, color, surface texture, translucency/characterization. The mesial and distal papillas are measured for absence, completeness, incompleteness, while the other variables are measured by comparing them with the contralateral teeth in terms of vertical level (score of 2), small (≤1 mm) discrepancy (score of 1), or large (≥1 mm) discrepancy (score of 0). The maximum score will be 14 for PES and 10 for WES, which will mean a perfect match for soft tissue and hard tissue respectively.
patient's satisfaction: VAS scale
Patient satisfaction is analyzed by means of a VAS scale
Digital valuation of emergency profile
The prosthetic contour is evaluated with the fingerprint to evaluate the angular width of the emergence profile. The amplitude of the angle evaluated is that formed between the emergence profile (part of the crown in contact with the soft tissues) and the long axis of the tooth. The angle of the emergence profile is evaluated by making a digital impression on the plaster model with the crowns inserted in the prosthetic abutment of the master model, first with the temporary and then with the definitive. The unit of measurement expressed by the digital instrument is always the same so it is a single measurement carried out in two different times.
Evaluation of the interproximal papilla
Once the final crowns have been cemented, the distance between the point of contact and the interproximal papilla is measured.

Full Information

First Posted
September 30, 2019
Last Updated
November 2, 2019
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT04151316
Brief Title
Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth
Official Title
Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Tissue Defect, Dental Prosthesis Complication, Dental Prosthesis Failure, Tissue Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vertical group
Arm Type
Experimental
Arm Title
horizontal group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
crown preparation
Intervention Description
includes tooth preparation
Intervention Type
Procedure
Intervention Name(s)
vertical preparation
Intervention Description
type of vertical preparation on the tooth that accepts the crown
Intervention Type
Procedure
Intervention Name(s)
horizontal preparation
Intervention Description
type of horizontal preparation on the tooth that accepts the crown
Primary Outcome Measure Information:
Title
variation of gingival thickness
Description
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.
Time Frame
12 months
Title
variation of gingival thickness digital
Description
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.
Time Frame
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 Outcome Measure Information:
Title
BOP
Description
percentage of bleeding of the gingival sulcus of all dental elements using a millimeter periodontal probe
Time Frame
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)
Title
PPD
Description
probing depth (PD), recorded in millimetres at 6 points for each tooth using a millimeter periodontal probe
Time Frame
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)
Title
Recessions
Description
relative gingival recession (rREC), measured at 6 points for each tooth as the distance from the gingival margin (GM) to the apical edge of the acrylic template previously using a millimeter periodontal probe
Time Frame
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)
Title
aesthetic value
Description
Aesthetic evaluation of soft tissue is performed with the Pink Aesthetic Score/White Aesthetic Score (PES/WES). The PES evaluation consists of 7 variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue texture and color. Mucosa is evaluated with WES, which consists of 5 variables: tooth shape, volume, color, surface texture, translucency/characterization. The mesial and distal papillas are measured for absence, completeness, incompleteness, while the other variables are measured by comparing them with the contralateral teeth in terms of vertical level (score of 2), small (≤1 mm) discrepancy (score of 1), or large (≥1 mm) discrepancy (score of 0). The maximum score will be 14 for PES and 10 for WES, which will mean a perfect match for soft tissue and hard tissue respectively.
Time Frame
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)
Title
patient's satisfaction: VAS scale
Description
Patient satisfaction is analyzed by means of a VAS scale
Time Frame
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).
Title
Digital valuation of emergency profile
Description
The prosthetic contour is evaluated with the fingerprint to evaluate the angular width of the emergence profile. The amplitude of the angle evaluated is that formed between the emergence profile (part of the crown in contact with the soft tissues) and the long axis of the tooth. The angle of the emergence profile is evaluated by making a digital impression on the plaster model with the crowns inserted in the prosthetic abutment of the master model, first with the temporary and then with the definitive. The unit of measurement expressed by the digital instrument is always the same so it is a single measurement carried out in two different times.
Time Frame
The angle of the emergence profile is evaluated first with the temporary (T0 first week) and then with the definitive(T1 after 3 month).
Title
Evaluation of the interproximal papilla
Description
Once the final crowns have been cemented, the distance between the point of contact and the interproximal papilla is measured.
Time Frame
gap between the most coronal part of the papilla and the point of contact is measured and re-evaluated at 3 months (t2), 6 months (t3), 12 months (t4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Tetè, DDS
Phone
3806479820
Email
tetegiulia92@gmail.com
Facility Information:
Facility Name
Giulia
City
Milano
State/Province
Italy/MI
ZIP/Postal Code
20123
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Tetè, DDS
Phone
3806479820
Email
tetegiulia92@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
we'll set up electronic databases for each patient.
IPD Sharing Time Frame
in a year and a half, we'd produce the data and leave it available.

Learn more about this trial

Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

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