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Minimally invasive treatment of teeth with deep caries and a history of spontaneous pain

Vital Pulp Therapy in permanent teeth with signs of Pulpitis - VPTPTSP Vital Pulp Therapy in Permanent Teeth with Signs of Pulpitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-6tm67h3
Enrollment
Unknown
Registered
2021-05-04
Start date
2021-03-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

Study 1 - Experimental group: 51 patients over 7 years of age with spontaneous toothache, capable of being suppressed with analgesic medication or spontaneously who will receive restoration after part
E06.323.428

Sponsors

Fundação de Amparo a Pesquisa do estado do Rio Grando do Sul
Lead Sponsor
Fundação de Amparo a Pesquisa do estado do Rio Grando do Sul
Collaborator

Eligibility

Age
7 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with permanent tooth (older than 7 years) with a deep caries lesion with a clinical pulp diagnosis of moderate pulpitis (irreversible pulpitis) will be included in the study, according to the pulp diagnostic system described by Wolters and collaborators in 2017 (Moderate pulpitis - Clear symptoms, strong, heightened and prolonged reaction to cold (-20ºC)), which can last for minutes; Possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication; With or without periodontal ligament spacing thickening; Patients who accept to participate, their guardians authorize to participate in the research, and sign the free and informed consent form (TCLE) will be included.

Exclusion criteria

Exclusion criteria: Patients who do not have enough remaining dental tissue to receive direct restoration will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the maintenance of pulp vitality, analyzed through the absence of spontaneous pain, fistula, edema, and sensitivity to vertical and horizontal percussion. In the test group (RSTC) the thermal sensitivity test (-20ºc) and measurement of oxygen saturation of teeth in 7 days / 180 days and then up to 5 years after treatment. Periapical radiographic analysis with no periapical process and/or root resorption will be analyzed at the cutoff points –180 days and then up to 5 years after treatment.

Secondary

MeasureTime frame
Modification of the painful sensation reported by the patient through the visual analog scale (VAS) performed in the pre-treatment and 7 after the treatment. Pain relief (painful sensation modification) will be defined as the difference in VAS scores (mm) between post-treatment pain and pre-treatment pain (median and 25-75 quartile). ;Deposition of mineralized tissue (tertiary dentin [test group - RSTC] or dentin bridge [control group - PT]) below the restorations.;Evaluation of the restoration in relation to fracture, loss of part or all restorative material and the need for repairs.

Countries

Brazil

Contacts

Public ContactClarissa Parolo

Universidade Federal do Rio Grande do Sul

fatturiparolo@yahoo.com+555199512845

Outcome results

None listed

Source: REBEC (via WHO ICTRP)