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Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols

Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05181813
Enrollment
30
Registered
2022-01-06
Start date
2020-10-17
Completion date
2022-08-30
Last updated
2023-01-10

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

Conditions

Primary Teeth, Pulp Necroses, Infected Pulp, Root Canal Treatment

Keywords

Pediatric Dentistry, Pulpectomy, Infected Pulp, Necrotic Pulp, Gingerols, Calcium Hydroxide, Metapex, Ginge-Cal

Brief summary

This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

Detailed description

Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

Interventions

PROCEDUREGinge-Cal

Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)

PROCEDUREMetapex

Fill the infected root canal of of primary teeth with Metapex

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Selected children will be divided randomly into 2 groups: Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide. Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

1. The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments. 2. Parents signed the consent to participate in the study. 3. Absence of any systemic disease, which would contraindicate pulp therapy. 4. Child didn't have any history of a sensitive reaction to any component of used materials. 5. Present half to two third of tooth root or more 6. Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.

Exclusion criteria

All that does not correspond to inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of primary teeth with control necrotic pulp by clinical examinationUp to 18 monthsThe primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age.
Percentage of primary teeth with control necrotic pulp by radiographic examinationUp to 18 monthsThe primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026