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Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars

ConditionDeep Caries in Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorOctober University for Modern Sciences and Arts

About this trial

This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient and parent showing cooperation and compliance.

Children 4-9 years old.

Vital carious primary(s) with complete root formation.

Asymptomatic teeth or without clinical symptoms of spontaneous pain.

Disqualifiers

History of any systemic disease.

Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.

The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).

Trial design

Design model

Parallel

Treatments tested in this trial

  • NeoPutty MTA

    Drug

    NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown.

  • Formocresol

    Drug

    A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Arm A: NeoPutty MTA PulpotomyExperimental treatment 1 intervention
Group B: Arm B: Formocresol PulpotomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain

Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.

Time frame
1 week postoperatively, 3 months, 6 months, 9 months and 12 months

Secondary outcomes

1

Pain on percussion

Description: Presence or absence of pain on percussion during clinical follow-up visits.

Time frame
3 months, 6 months, 9 months and 12 months
2

Presence of sinus tract, fistula or abscess

Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.

Time frame
3 months, 6 months, 9 months and 12 months
3

Tooth mobility

Description: Tooth mobility assessed clinically using a mobility scoring system ranges from 0-3 were (score 0 the best) indicates no mobility and (score 3 the worst) indicates vertical and horizontal mobility.

Time frame
3 months, 6 months, 9 months and 12 months
4

Widening of Periodontal Ligament Space

Radiographic evidence of widening of the periodontal ligament space assessed using standardized periapical radiographs. Recorded as Present / Absent.

Time frame
6 months and 12 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

October University for Modern Sciences and Arts

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: