Success Rate of Three Capping Materials

Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial

A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) & the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six & 12 months.

Study Overview

• Status: Completed
• Conditions: Caries
• Intervention / Treatment: Procedure: Nanohydroxyapatite Pulpotomy; Procedure: MTA pulpotomy; Procedure: Formocresol Pulpotomy

Detailed Description

The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.

Procedures:

Preoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.

The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min.

In Group 1:

Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.

In Group 2:

The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.

Group 3:

A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.

All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.

Clinical and radiographic evaluation:

All treated patients were followed up at one, three , six & 12 months after the pulpotomy.

The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption

Statistical analysis:

Data were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, +202
    • Randa Youssef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Absence of tenderness to percussion.

  • Absence of physiologic or pathologic tooth mobility.
  • No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
  • Restorable teeth.
  • Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection

Exclusion Criteria:

• • Evidence of necrosis after access cavity preparation.

  • Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nanohydroxyapatite Pulpotomy; Biphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite In Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy	Procedure: Nanohydroxyapatite Pulpotomy; Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic
Active Comparator: MTA Pulpotomy; Angelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation at one, three ,six & 12 months after pulpotomy.	Procedure: MTA pulpotomy; Angleus grey MTA
Active Comparator: Formocresl Pulpotomy; Buckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically.	Procedure: Formocresol Pulpotomy; Buckley's Fromocresol. diluted full strength foromocresol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	abscence of all clinical signs and symptoms of failure	12 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic success rate	Absence of any radiographic signs of failure	12 Month

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Abd Al Gawad RY, Hanafy RMH. Success rate of three capping materials used in pulpotomy of primary molars: A randomized clinical trial. Saudi Dent J. 2021 Nov;33(7):560-567. doi: 10.1016/j.sdentj.2020.08.007. Epub 2020 Aug 29.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: MTA; Pulpotomy; Formocresol; Nanohydroxyapatite
• Other Study ID Numbers: 181053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study design and procedures
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No