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Revolutionizing Kids Dentistry: The Potential of Amniotic Membranes for Tooth Pulp Treatment

Evaluating the Therapeutic Efficacy of Human Amniotic Membrane as a Pulpotomy Agent for Primary Mandibular Molars: Randomized Clinical Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085104
Enrollment
45
Registered
2025-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Group 1 Human Amniotic Membrane (HAM): The Human amniotic membrane (AM) is avascular which holds several metabolic functions. It is responsible for the transport of water and soluble m

Sponsors

Devshri vaja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinical: 1. Children who exhibit cooperative or potentially cooperative behaviour (Frankel rating 2 and 3) and do not have any underlying medical, physical, or learning disabilities. 2. Prospective participants must have no reported history of continuous pain, tenderness on percussion, pathological mobility, sinus tract, or evidence of pulpal degeneration on radiographic examination. 3. Presence of either symptom free tooth with a deep carious lesion (ICDAS score 5 and 6) or tooth which is showing symptoms of reversible pulpitis. 4. Participants with primary mandibular molars that can be pulpotomised and are suitable for restoration. 5. Patients without any underlying medical, physical, or learning disabilities. 6. Haemorrhage from the amputated pulp stumps that can be readily controllable within 5 minutes through the use of a sterile moist cotton pellet. Radiological: 1. Individuals with carious lesions approaching the pulp. 2. Molars featuring at least 2/3 of the root structure. 3. Molars should exhibit a normal radiographic appearance with healthy supporting tissues. 4. Absence of pathological root resorption, no widening of periodontal ligament space (PDL), and no furcal radiolucency.

Exclusion criteria

Exclusion criteria: 1. Teeth with shallow carious lesions (ICDAS score 1- 4) 2. Patients with a history of pain, tenderness on percussion, presence of tooth mobility, abscess, or sinus tract. 3. Teeth experiencing root resorption, furcal radiolucency, or widening of periodontal ligament space. 4. Primary molars with previous endodontic treatment. 5. Individuals with underlying medical, physical, or learning disabilities.

Design outcomes

Primary

MeasureTime frame
primary outcomes :- The outcome of the study will be assessed according to the CLINICAL criteria given by Modified Zurn and Seale et al. (2008) criteriaTimepoint: At baseline, 1 month, 3 months, 6 months and 9 months

Secondary

MeasureTime frame
primary outcomes :- The outcome of the study will be assessed according to the RADIOGRAPHIC criteria given by Modified Zurn & Seale et al. (2008) criteriaTimepoint: At baseline, 1 month 3 months 6 months & 9 months

Countries

India

Contacts

Public ContactDevshri vaja

King Georgs Medical University

rajkids2000@yahoo.co.in9450849528

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026