Skip to content

Clinical study of two root filling materials in treating a vital pulp of deciduous tooth

Double-blind randomized clinical trial of the performance of two root filling materials in biopulpectmies of primay molars

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-93x9vcb
Enrollment
Unknown
Registered
2022-11-03
Start date
2019-01-04
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

Pulpits

Interventions

This is a double-blind, randomized controlled clinical trial. A total of 40 lower deciduous molars of children will be selected according to the eligibility criteria, the selection of the filling past
J01.637.051.339.859

Sponsors

Universidade Federal de Alfenas
Lead Sponsor
Universidade Federal de Alfenas
Collaborator

Eligibility

Age
4 Years to 11 Years

Inclusion criteria

Inclusion criteria: First or second deciduous lower molar with deep caries and pulp vitality; provoked or spontaneous pain that does not relieve with the use of medication; in case of teeth with provoked pain, absence of hemostasis in adequate time up to 5 minutes, after attempted pulpotomy; absence of fistula or abscess; absence of bone rarefaction on radiographic examination; absence of internal or external resorption of more than two thirds of the root; tooth restorative possibility

Exclusion criteria

Exclusion criteria: Children with difficult behavior and who do not cooperate with the treatment; children who have systemic health problems; teeth with periapical lesion or interradicular bone rarefaction; internal and or external resorption involving more than one thirds of the root length; teeth with less than two thirds of the root remainder; rupture of the pericoronary sac; restorative impossibility; teeth that have had some kind of previous pulp treatment; patients using antibiotics

Design outcomes

Primary

MeasureTime frame
Expected outcome1: The deciduous teeth treated were methods during a period of 3, 6 and 9 months, selected through clinical and radiographic findings, the finding were considered clinical success, with no pain, no sensitivity to percussion, no abscess/ fistula absence of pathological mobility, considering 5% of significance of power of 80% and of continuity of 0.5 for the times of knowledge. ;Expected outcome 1: The treated deciduous teeth were evaluated during a period of 3, 6 and 9 months, verified through the clinical and radiographic method. periapical lesion and presence of intact periodontal ligament, considering 5% of significance, power of 80% and correlation of 0.5 for the three times evaluated.;Expected Outcome 3: It was also evaluated the condition of the filling material and the conditions and type of the definitive restorations during a period of 3, 6 and 9 months, verified through clinical success, from the observation of integrity and marginal discoloration, its anatomical shape , surface roughness and secondary caries, considering 5% significance, 80% power and 0.5 correlation for the three times evaluated.

Secondary

MeasureTime frame
Outcome 2: The percentage of success and radiography was 78.9% Calcium Hydroxide Paste and polyethylene glycol 400 thickened with zinc oxide for the and 81.0% Calcium Hydroxide Paste and iodoform.;Outcome Found 1: Clinical success rate was 100% of the Zinc Oxide-thickened Calcium Hydroxide Paste and Polyethylene Glycol 400 Paste as with Calcium Hydroxide Paste.;Outcome 3: The restorations presented satisfactory clinical behavior, in 72.5% of the cases, only 27.5% of the sample had failures in the restorations and without the occurrence of secondary caries.

Countries

Brazil

Contacts

Public ContactAmanda Caldeira

Universidade Federal de Alfenas

amanda.valentim4@gmail.com+55(35)3701-9000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)