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Completed

NCT Number: NCT03770871

Indirect Pulp Treatment in Primary Molars

This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Oral and Dental Medicine

Cairo, 11553, Egypt

About this study

Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"

In addition to:

I-Subjects:

  • Medically free children, their parent(s) accepts to sign the informed consent.
  • Age range from 4-8 years.

II-Molars:

  • Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
  • Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
  • Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria

I-Subjects:

  • Uncooperative children.
  • Parents unable to attend follow up visits (even after explaining the importance of recall visits).

II-Molars:

  • History of spontaneous pain (to exclude reversible pulpitis).
  • Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
  • Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

Treatment and study plan

Indirect pulp treatment using Dycal (TM)

Drug

Partial caries removal and protection of the dental pulp with biocompatible material

Other names: Indirect pulp capping

Indirect pulp treatment using Vitrebond (TM )

Drug

Partial caries removal and protection of the dental pulp with biocompatible material

Other names: Indirect pulp capping

Primary outcomes

  1. Number of cases reporting postoperative pain

    Time frame: 12 months

    Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure

  2. Number of cases reporting swelling

    Time frame: 12 months

    Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure

  3. Number of cases reporting sinus

    Time frame: 12 months

    Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure

  4. Number of cases reporting fistula

    Time frame: 12 months

    Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure

  5. Number of cases reporting tooth mobility

    Time frame: 12 months

    Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure

Secondary outcomes

  1. Number of cases reporting external root resorption

    Time frame: 12 months

    Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

  2. Number of cases reporting internal root resorption

    Time frame: 12 months

    Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

  3. Number of cases reporting furcation involvement

    Time frame: 12 months

    Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

  4. Number of cases reporting widening of periodontal membrane space

    Time frame: 12 months

    Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

  5. Number of cases reporting periapical radiolucency

    Time frame: 12 months

    Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial

Acronym: RCT

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 10, 2018
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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