Prosthetic Tissue DefectNCT04151316
Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth
A study testing crown preparation, vertical preparation and horizontal preparation in people with Prosthetic Tissue Defect and Dental Prosthesis Complication, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Tissue Defect, Dental Prosthesis Complication, Dental Prosthesis Failure
- What is being tested?
- crown preparation, vertical preparation and horizontal preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2019to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Giulia
Milan, Italy/MI, 20123
Giulia Tetè, DDS, 3806479820, tetegiulia92@gmail.com
About this study
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
- Being tested
- crown preparation, vertical preparation, horizontal preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crown preparationProcedure or surgery
includes tooth preparation
vertical preparationProcedure or surgery
type of vertical preparation on the tooth that accepts the crown
horizontal preparationProcedure or surgery
type of horizontal preparation on the tooth that accepts the crown
| Study group | Role | What they receive |
|---|---|---|
| vertical group | Experimental | Not described Receives: Procedure: crown preparation; Procedure: vertical preparation |
| horizontal group | Experimental | Not described Receives: Procedure: crown preparation; Procedure: horizontal preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
percentage of bleeding of the gingival sulcus of all dental elements using a millimeter periodontal probe
Measured: 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
probing depth (PD), recorded in millimetres at 6 points for each tooth using a millimeter periodontal probe
Measured: 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
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
Measured: 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
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.
Measured: 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
Patient satisfaction is analyzed by means of a VAS scale
Measured: 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 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.
Measured: The angle of the emergence profile is evaluated first with the temporary (T0 first week) and then with the definitive(T1 after 3 month).
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Tissue DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Enrico Gherlone, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151316
- Sponsor's protocol ID
- BOPT 1 unisr
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we'll set up electronic databases for each patient.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth
- ClinicalTrials.gov ID
- NCT04151316
- Acronym / sponsor ID
- BOPT 1 unisr
- Conditions
- Prosthetic Tissue Defect, Dental Prosthesis Complication, Dental Prosthesis Failure, Tissue Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertical group | Experimental | Procedure: crown preparation, Procedure: vertical preparation |
| horizontal group | Experimental | Procedure: crown preparation, Procedure: horizontal preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- contraindication to dental treatment
- active periodontal disease
- systemic diseases that may affect periodontitis
- Pregnant women
- Patients in orthodontic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crown preparationincludes tooth preparation | Procedure or surgery | horizontal group, vertical group |
| vertical preparationtype of vertical preparation on the tooth that accepts the crown | Procedure or surgery | vertical group |
| horizontal preparationtype of horizontal preparation on the tooth that accepts the crown | Procedure or surgery | horizontal group |
Primary outcome
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.
7 secondary outcomes
BOP
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)
PPD
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)
Recessions
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)
aesthetic value
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)
patient's satisfaction: 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).
Digital valuation of emergency profile
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).
Evaluation of the interproximal papilla
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: Yes. we'll set up electronic databases for each patient.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crown preparation, vertical preparation and horizontal preparation in people with Prosthetic Tissue Defect and Dental Prosthesis Complication, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Tetè, DDS (3806479820, tetegiulia92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of gingival thickness (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.