Success Rate of Three Capping Materials

NCT03833557 | Completed

• 1 other identifier: 181053
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caries

Keywords

Formocresol; MTA; Nanohydroxyapatite; Pulpotomy

Outcome Measures

Primary Outcomes (1)

• Clinical success rate

  abscence of all clinical signs and symptoms of failure

  12 Month

Secondary Outcomes (1)

• Radiographic success rate

  12 Month

Study Arms (3)

Nanohydroxyapatite Pulpotomy

ACTIVE COMPARATOR

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

MTA Pulpotomy

ACTIVE COMPARATOR

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

Formocresl Pulpotomy

ACTIVE COMPARATOR

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

Interventions

Nanohydroxyapatite Pulpotomy PROCEDURE

Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic

Nanohydroxyapatite Pulpotomy

MTA pulpotomy PROCEDURE

Angleus grey MTA

MTA Pulpotomy

Formocresol Pulpotomy PROCEDURE

Buckley's Fromocresol. diluted full strength foromocresol

Formocresl Pulpotomy

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Randa Youssef

Giza, +202, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34803301 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 7, 2019
• Study Start: May 5, 2017
• Primary Completion: January 10, 2019
• Study Completion: January 14, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)