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Evaluation of the effect of Dental Adhesive System in preventing Pigmentation of deciduous teeth after root canal treatment using a non-instrumental dental technique: a randomized clinical study

Effect of the Adhesive System in preventing Coronary Pigmentation after non-instrumental endodontic treatment in primary teeth: a randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6359s54
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-01-14
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Decíduos tooth, dental pulp necrosis

Interventions

This is a randomized controlled blind clinical study, since the allocation will not be disclosed to the evaluators. Due to the difference between the procedures performed, the operator cannot be blind
s liquid and aspiration in both groups. Following cleaning and drying of the pulp chamber, the antibiotic paste will be manipulated in a 1:1:2 ratio in 250 mg capsule

Sponsors

Faculdade de Odontologia de Piracicaba
Lead Sponsor
Faculdade de Odontologia de Piracicaba
Collaborator

Eligibility

Age
5 Years to 9 Years

Inclusion criteria

Inclusion criteria: Children from the municipality of Votorantim (São Paulo, Brazil) who use the municipality's public dental service; children aged 5 to 9 years; children of both sexes; children who require endodontic treatment in at least one upper or lower deciduous molar, with a diagnosis of irreversible pulpitis or pulp necrosis; teeth with sufficient dental structure to allow absolute isolation of the operative field and subsequent restoration

Exclusion criteria

Exclusion criteria: Children who present any systemic alteration; history of allergic reaction to any medication; children who have used antibiotics in the last three months from the date of the examination; children with systemic manifestation (fever and extraoral abscess) resulting from the infectious process of dental origin; teeth that present obliteration of the pulp canal; involvement of the bone crypt of the permanent tooth

Design outcomes

Primary

MeasureTime frame
The aim is to evaluate the effect of the adhesive system on reducing or preventing pigmentation of deciduous teeth after non-instrumental endodontic treatment, as well as the clinical and radiographic results during 12 months of follow-up. The aim is to clinically observe the absence of signs and symptoms associated with the infectious and inflammatory process, such as: spontaneous pain, soft tissue changes, fistula, edema and pathological tooth mobility, at 15 days, 1, 3, 6 and 12 months of follow-up. Also, the cases are being radiographically evaluated at intervals of 6 and 12 months by visual analysis of periapical radiographs. A decrease or disappearance of initial periapical and/or interradicular radiolucency and absence of new radiolucency in comparison to the initial radiograph will be observed

Secondary

MeasureTime frame
The paste will show good clinical performance, with no signs and symptoms associated with the infectious and inflammatory process in the 15-day, 1-, 3-, 6- and 12-month follow-up period. It is expected that the treatment of deciduous teeth by the Non-Instrumental Endodontic Technique using CTZ-based paste (Chloramphenicol, Tetracycline and Zinc Oxide and Eugenol) will show a high rate of clinical and radiographic success. When comparing the interventions, a difference in the change in coronal color is expected only in the group with the antibiotic paste compared to the initial color of the treatment and that no tooth pigmentation will occur in the experimental group

Countries

Brazil

Contacts

Public ContactJéssica Gomes Geraldi

Faculdade de Odontologia de Piracicaba da Universidade de Campinas

jessica_sandim@hotmail.com+55 (19)2106-5209

Outcome results

None listed

Source: REBEC (via WHO ICTRP)