Clinical trial NCT04151316: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthetic Tissue Defect
Dental Prosthesis Complication
Dental Prosthesis Failure
Tissue Injury
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: variation of gingival thickness
timeFrame: 12 months
measure: variation of gingival thickness digital
timeFrame: 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:
measure: BOP
timeFrame: 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)
measure: PPD
timeFrame: 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)
measure: Recessions
timeFrame: 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)
measure: aesthetic value
timeFrame: 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)
measure: patient's satisfaction: VAS scale
timeFrame: 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).
measure: Digital valuation of emergency profile
timeFrame: The angle of the emergence profile is evaluated first with the temporary (T0 first week) and then with the definitive(T1 after 3 month).
measure: Evaluation of the interproximal papilla
timeFrame: 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)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Giulia
state: Italy/MI
Study officials:
References: