Sodium Hypoclorite as an Antibacterial Agent Prior to Pulpotomies

NCT04270318 | Completed DMC

• 1 other identifier: 2012-TEZ-07
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: The aim of this study was to report the 24-Month radiographical and histological outcome on these previously reported calcium hydroxide (CH) and mineral trioxide aggregate (MTA) pulpotomies using of five percent sodium hypochlorite (NaOCl) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent. Materials and Methods: 128 primary molars were randomly divided into two main groups according to pulpotomy material (CH/MTA) and into two sub-groups according to selected the antibacterial agent (NaOCl/physiologic saline) used in the pulpotomy procedure. After these procedures, teeth were followed radiographically for 24 months. Thirty-four successfully treated teeth whose successors roots had completed formation of at least two-thirds of their lengths were extracted for histological evaluation. Fisher's-exact test, Pearson's-chi-square test and MannWhitneyU test with Bonferroni correction were used for statistical analysis.

Conditions

Pulpotomy; Primary Teeth

Keywords

calcium hydroxide; mineral trioxide aggregate; sodium hypochlorite

Outcome Measures

Primary Outcomes (4)

• Clinical success rate of pulpotomy

  Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.

  Change of clinical success from baseline at 12 month

• Clinical success rate of pulpotomy

  Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.

  Change of clinical success from Baseline at 24 month

• Radiographic success rate of pulpotomy

  For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.

  Change of radiographicsuccess from baseline at 12 month

• Radiographic success rate of pulpotomy

  For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.

  Change of radiographicsuccess from baseline at 24 month

Secondary Outcomes (1)

• Histological success rate of indirect pulp treatment

  up to 30 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation).]

Study Arms (4)

CH pulpotomy-control

ACTIVE COMPARATOR

After hemorrhage control, pulp chamber was cleansed with physiologic saline prior the CH pulpotomy.Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany).

Other: CH Pulpotomy, physiologic saline

CH pulpotomy-NaOCl

EXPERIMENTAL

After hemorrhage control,pulp chamber was cleansed with 5% NaOCl for 30 s prior the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany).

Other: CH pulpotomy, NaOCl

MTA pulpotomy-control

ACTIVE COMPARATOR

After hemorrhage control, pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs.

Other: MTA Pulpotomy, physiologic saline

MTA pulpotomy-NaOCl

EXPERIMENTAL

After hemorrhage control, pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs.

Other: MTA pulpotomy, NaOCl

Interventions

CH Pulpotomy, physiologic saline OTHER

Pulp chamber was cleansed with physiologic saline for 30 s.

CH pulpotomy-control

CH pulpotomy, NaOCl OTHER

Pulp chamber was cleansed with 5 % NaOCl for 30 s.

CH pulpotomy-NaOCl

MTA Pulpotomy, physiologic saline OTHER

Pulp chamber was cleansed with physiologic saline for 30 s.

MTA pulpotomy-control

MTA pulpotomy, NaOCl OTHER

Pulp chamber was cleansed with 5 % NaOCl for 30 s.

MTA pulpotomy-NaOCl

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Each child had at least two previously untreated lower 2nd primary mandibular molars with nearly equal carious involvement that required pulpotomies but showed positive response to vitality tests (electrical pulp test and cold stimulation)
• The children were healthy and cooperative
• Moderate response to chemical and thermal stimuli.
• Teeth would be restorable with stainless steel crowns.

You may not qualify if:

• Signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response),
• Presence of percussion or palpation,
• Pathological mobility,
• Infectious symptoms such as fistula or abscess,
• Discoloration in the clinical examination,
• Presence of radiolucency in the furcation or periodical regions thickening of the periodontal spaces
• Internal or external root resorption.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2017
• Last Updated: February 17, 2020

Record last verified: 2020-02