Evaluation of Zinc Oxide Eugenol and Iodoform-Calcium Hydroxide as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorOctober University for Modern Sciences and Arts

About this trial

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as root canal filling materials in primary molars prepared using either rotary or manual instrumentation techniques. Forty-four teeth from children aged 5-8 years indicated for pulpectomy will be randomly allocated into four equal groups based on the combination of instrumentation method and filling material. Clinical parameters-pain, mobility, and sensitivity-will be assessed using standardized scales, while radiographic outcomes, including root resorption and bone density, will be evaluated using Cone Beam Computed Tomography (CBCT) at baseline, 6 months, and 12 months. The study seeks to determine which obturation material and canal preparation technique yield superior healing, adaptation, and resorption compatible with the physiological process of primary tooth exfoliation. Findings are expected to inform evidence-based selection of endodontic materials and instrumentation methods in pediatric dentistry.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Apparently healthy cooperative children indicated for partial pulpectomy.

Restorable primary molars.

No mobility, or external pathological root resorption.

Disqualifiers

Uncooperative children.

Children with systemic medical illness.

More than 2/3 of root resorbed.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Instrumentation

    Procedure/Surgery

    Root canal preparation of primary molars will be performed using manual stainless-steel hand files with conventional step-back technique for cleaning and shaping of the root canals.

  • Iodoform-Calcium Hydroxide (Metapex)

    Drug

    Metapex (iodoform-calcium hydroxide paste) will be used as the obturating material for filling the prepared root canals of primary molars following pulpectomy.

  • Rotary Instrumentation

    Procedure/Surgery

    Root canal preparation of primary molars will be performed using nickel-titanium rotary instruments according to the manufacturer's instructions to achieve effective cleaning and shaping of the root canals.

  • Zinc Oxide Eugenol (ZOE)

    Drug

    Zinc oxide eugenol paste will be used as the obturating material for filling the prepared root canals of primary molars following pulpectomy.

Treatment groups

44 Participants
are divided into 4 treatment groups
Group A: Arm A: Manual Instrumentation and MetapexExperimental treatment 2 interventions
Group B: Arm B: Rotary Instrumentation and MetapexExperimental treatment 2 interventions
Group C: Arm C: Manual Instrumentation and ZOEActive comparator 2 interventions
Group D: Arm D: Rotary Instrumentation and ZOEActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Radiographic Success

Radiographic success will be assessed by evaluating root resorption in treated primary molars. Cone Beam Computed Tomography (CBCT) will be used to measure the degree of root resorption in millimeters, allowing comparison between zinc oxide eugenol (ZOE) and iodoform-calcium hydroxide (Metapex) obturation materials in canals prepared by rotary and manual instrumentation techniques.

Time frame
Baseline, 6 months, and 12 months

Secondary outcomes

1

Postoperative Pain

Pain will be evaluated using the Wong-Baker FACES Pain Rating Scale. Patients will self-report pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) during follow-up visits after pulpectomy.

Time frame
Baseline, 6 months, and 12 months
2

Tooth Mobility

Tooth mobility will be assessed clinically using Miller's Mobility Index by applying gentle pressure with a dental instrument to evaluate the degree of horizontal and vertical movement of the treated primary molars where 0 (no mobility) to 3 (more than 1mm vertical and horizontal mobility) during clinical examination.

Time frame
Baseline, 6 months, and 12 months
3

Tooth Sensitivity

Tooth sensitivity will be evaluated using the Numeric Rating Scale (NRS), where patients will rate sensitivity from 0 (no sensitivity) to 10 (extreme sensitivity) during clinical examination.

Time frame
Baseline, 6 months, and 12 months

Other outcomes

Sponsors and contacts

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