Clinical trial NCT06524076: Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA
Official title: Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulp Disease, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Detailed description: Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.

1. Informed consent from participating children's parents.
2. Baseline records photographs, percussion test, periapical radiograph and personal data collection.
3. Diagnostic chart with personal, medical and dental history will be filled.
4. Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
6. Preoperative and Postoperative photographs will be taken.

Eligibility criteria: Inclusion Criteria:

* Patients:

  * Aged 4-7 years, in good general health and medically within normal.

Teeth:

* Restorable mandibular second primary molars.
* History of reversible pulpitis.

Preoperative radiograph:

* Absence of periapical or inter-radicular radiolucency.
* Absence of widening of periodontal ligaments (PDL) space.
* Absence of internal or external root resorption.

Exclusion Criteria:

* Patients:

  * With systemic disorders.
  * Physical or mental disabilities.
  * Unable to attend follow-up visits.
  * Refusal of Participation.
  * Refusal to sign the informed consent.

Teeth:

* Previously accessed teeth.
* Mobile mandibular second primary molar.
* Swelling in the vestibule or on palpation.
* Pain on percussion.

Primary outcomes:
measure: Postoperative pain
timeFrame: one week postoperative
measure: Swelling/ Fistula
timeFrame: 3, 6, 9, 12 months
measure: Mobility
timeFrame: 3, 6, 9, 12 months
Secondary outcomes:
measure: Radiographic success
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dental Medicine, Cairo University
name: Hany M. Saber, PHD
role: STUDY_CHAIR
affiliation: Faculty of Dental Medicine, Cairo University
name: Hanaa M. Abd El Moniem, PHD
role: STUDY_DIRECTOR
affiliation: Faculty of Dental Medicine, Cairo University
name: Yara A. Badr, Masters
role: PRINCIPAL_INVESTIGATOR
References: