Skip to content

The effectiveness of a pre-made filling for closing an open-apex tooth root

Evaluating the efficacy of prefabricated bio-root inlay in apexification success in necrotic immature permanent teeth: a randomized control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10899754
Enrollment
30
Registered
2023-11-08
Start date
2023-11-15
Completion date
Unknown
Last updated
2023-11-20

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

Conditions

Necrotic immature permanent upper incisors in children Oral Health

Interventions

Thirty necrotic maxillary immature incisors from healthy children aged between 7-11 years will be randomly divided into two groups using http://www.randomization.com: Group A (control)

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with one or more maxillary incisors with an open apex root (defined as root with root canal size equal to or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm

Exclusion criteria

Exclusion criteria: 1. Children with systemic diseases that compromised their general immune status 2. Uncooperative (definitely negative on the Frankl's behavioral scale) 3. Unrestorable incisors

Design outcomes

Primary

MeasureTime frame
1. Clinical evaluation: Patients of both groups will be recalled after 1, 3, 7, and 14 days of treatment and during radiographical assessment periods (3, 6 and 12 months), where they will be asked to rate their pain on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = no hurt, 1 = hurts a little bit, 2 = hurts a little more 3 = hurts even more, 4 = hurts a whole lot, and 5 = hurts worst. Moreover, the presence of fistula, swelling, and movement will be recorded. 2. Radiographical assessment: After coronal restoration is completed a control x-ray will be taken. The periapical status will be assessed at the time of obturation-restoration, 3, 6, and 12 months following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system: (1) normal periapical structures; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; (5) severe periodontitis with exacerbating features. The teeth will be evaluated according to healed, healing or unsuccessful as a primary radiographical outcome.

Secondary

MeasureTime frame
1. Patient age (in years) and sex (male or female) determined during patient examination at the start of treatment 2. Required time for obturation of each case (in minutes) measured using a timer during the obturation phase 3. Child behavior (definitely positive, positive, and negative) will be determined by an external examiner during overall treatment visits 4. Extrusion of bioceramics (extrusion, or not extrusion) measured using a digital X-ray image at the end of the obturation phase 5. Apex diameter (in mm) and working length (in mm) measured using large sized K-file at the preparation phase

Countries

Syria

Contacts

Public ContactYasser Alsayed Tolibah
yasser94.tolibah@damascusuniversity.edu.sy+963 (0)988812044

Outcome results

None listed

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