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Topical agents for vital pulpotomy in primary teeth

Evaluation of the Effectiveness of Chitosan as dressing material in Primary Molars pulpotomy for Children Aged 5 – 8 Years

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001280190
Enrollment
60
Registered
2019-09-17
Start date
2019-11-11
Completion date
2020-02-11
Last updated
2019-09-30

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

Conditions

None listed

Brief summary

The aim of this study is to assess the clinical and radiographic effectiveness of Chitosan films compared with mineral trioxide aggregate (MTA) as dressing material in Primary Molars pulpotomy. Randomized controlled clinical trial The null hypothesis tested is that there is no statistically significant difference in clinical and radiographic success rates between Chitosan films and MTA.

Interventions

Second primary carious molars in children aged 5 - 8 years will be randomly divided into 2 groups: Arm1: (0.2 g Chitosan) Arm2: (0.2 g Mineral trioxide aggregate (MTA)) Each patient will receive vital pulpotomy in both second primary molars; in a split mouth design. Intra- and extraoral examinations of patients will be performed before the treatment and their initial radiologic examinations will be performed. Regional anesthesia will be performed, all cavity lesions will be removed, and an acces

Second primary carious molars in children aged 5 - 8 years will be randomly divided into 2 groups: Arm1: (0.2 g Chitosan) Arm2: (0.2 g Mineral trioxide aggregate (MTA)) Each patient will receive vital pulpotomy in both second primary molars; in a split mouth design. Intra- and extraoral examinations of patients will be performed before the treatment and their initial radiologic examinations will be performed. Regional anesthesia will be performed, all cavity lesions will be removed, and an access cavity will be prepared under the isolation of rubber dam. A low-speed sterile round bur will be used for removing coronal pulp. bleeding will be stopped using Sterile cotton pellets moistened with sterile saline. Then, pulp stumps will be covered with either chitosan films, or MTA. All pulpotomized teeth will be restored with stainless steel crowns. Interventions will be done by a pediatric dentistry resident and will take place in faculty of dentistry at Damascus university. Clinical and radiographic evaluation will be performed after 3, 6 and 9 Months

Sponsors

Damascus University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria of participants: 1. Healthy and Cooperative patients approving the trial. Inclusion Criteria of teeth: 1. Tooth is restorable. 2. Hemostasis achieved within 5 minutes during clinical procedure. 3. Presence of two-thirds of the root length radiographically.

Exclusion criteria

1. Clinical Signs and symptoms that indicate an infected pulp: abnormal tooth mobility, sensitivity to percussion, and gingival abscess or fistula associated with a tooth. 2. Radiographic evidence of pulp degeneration: internal or external root resorption, and interradicular or periapical bone destruction.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026