Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- variation of gingival thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
variation of gingival thickness
Time Frame: 12 months
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
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.
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 Outcomes
- 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))
- Digital valuation of emergency profile(The angle of the emergence profile is evaluated first with the temporary (T0 first week) and then with the definitive(T1 after 3 month).)
- 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))
- 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))
- 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))
- 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).)
- Evaluation of the interproximal papilla(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))
Investigators
Prof. Enrico Gherlone
Head of Dental School
Università Vita-Salute San Raffaele