Clinical trial NCT03770871: Indirect Pulp Treatment in Primary Molars
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: indirect pulp
primary
calcium hydroxide
resin modified glass ionomer
Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 88
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group with 1:1 allocation ratio
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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:

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

II-Molars:

1. 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).
2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
3. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria:

I-Subjects:

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

II-Molars:

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

Primary outcomes:
measure: Number of cases reporting postoperative pain
timeFrame: 12 months
measure: Number of cases reporting swelling
timeFrame: 12 months
measure: Number of cases reporting sinus
timeFrame: 12 months
measure: Number of cases reporting fistula
timeFrame: 12 months
measure: Number of cases reporting tooth mobility
timeFrame: 12 months
Secondary outcomes:
measure: Number of cases reporting external root resorption
timeFrame: 12 months
measure: Number of cases reporting internal root resorption
timeFrame: 12 months
measure: Number of cases reporting furcation involvement
timeFrame: 12 months
measure: Number of cases reporting widening of periodontal membrane space
timeFrame: 12 months
measure: Number of cases reporting periapical radiolucency
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine
Study officials:
affiliation: Cairo University
name: Shereen E Taha, Professor
role: PRINCIPAL_INVESTIGATOR
References: