NCT05719987

Brief Summary

Following the randomization procedure, patients will be divided into 2 groups (12 immature molars in each group): Group I will be treated with MTA as apical plug, whereas group II will be treated with Biodentine as apical plug. After working length determination, instrumentation and sterilizing root canals, apical plug will be done as following: Biodentine Group: Biodentine will be placed into the apical portion of canals. After 12 min the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown. MTA Group: MTA will be placed into the apical portion of canals, then a moist cotton pellet will be placed and the access cavity will be restored with temporary filling. Next day, temporary filling and the cotton pellet will be removed, then the coronal restoration will be performed as Biodentine group. Patients of both groups will be recalled for clinical and radiographical follow-up within 12 months after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

February 10, 2022

Last Update Submit

February 12, 2023

Conditions

Periapical Periodontitis

Keywords

ApexificationMTABiodentineImmature molars

Outcome Measures

Primary Outcomes (2)

  • Change in the apical lesion size

    The apexification procedure was judged to be radiographically successful if it demonstrated the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption. The apexification procedure was judged to be radiographically unsuccessful if the apical lesion size increased. The apexification procedure was judged to be doubtful if the apical lesion size didn't change

    after 1,3,6 and 12 months of root canal obturation

  • Change in the clinical assessment of success

    The apexification procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.

    1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months of root canal obturation

Secondary Outcomes (2)

  • Change in the apical lesion healing speed

    after 1,3,6 and 12 months of root canal obturation

  • Change in the periapical index (PAI)

    after 1,3,6 and 12 months of root canal obturation

Study Arms (2)

Biodentine Group

EXPERIMENTAL

study group

Other: Biodentine

MTA Group

OTHER

control group

Other: MTA

Interventions

BiodentineOTHER

After the endodontic procedure, Biodentine will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.

Biodentine Group
MTAOTHER

After the endodontic procedure, MTA will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.

MTA Group

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cooperative children.
  • Healthy children without any systemic disease or compromised immune status.
  • Children with first immature mandibular molar with at least one canal sized #60 or more with an apical lesion.

You may not qualify if:

  • Patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss).
  • Molars that cannot be restored (root fracture, unrestorable tooth, massive internal or external).
  • Molars that had previous endodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of dentistry.

Damascus, Al-Mazzeh Saint, Damascus P.O.Box 3062, Syria

Location

Related Publications (6)

  • Pace R, Giuliani V, Pini Prato L, Baccetti T, Pagavino G. Apical plug technique using mineral trioxide aggregate: results from a case series. Int Endod J. 2007 Jun;40(6):478-84. doi: 10.1111/j.1365-2591.2007.01240.x.

    PMID: 17403040BACKGROUND

  • Kandemir Demirci G, Kaval ME, Guneri P, Caliskan MK. Treatment of immature teeth with nonvital pulps in adults: a prospective comparative clinical study comparing MTA with Ca(OH)2. Int Endod J. 2020 Jan;53(1):5-18. doi: 10.1111/iej.13201. Epub 2019 Sep 3.

    PMID: 31397907RESULT

  • Alsayed Tolibah Y, Kouchaji C, Lazkani T, Abbara MT, Jbara S, Baghdadi ZD. Dental Care for a Child with Congenital Hydrocephalus: A Case Report with 12-Month Follow-Up. Int J Environ Res Public Health. 2021 Jan 29;18(3):1209. doi: 10.3390/ijerph18031209.

    PMID: 33572890RESULT

  • Vidal K, Martin G, Lozano O, Salas M, Trigueros J, Aguilar G. Apical Closure in Apexification: A Review and Case Report of Apexification Treatment of an Immature Permanent Tooth with Biodentine. J Endod. 2016 May;42(5):730-4. doi: 10.1016/j.joen.2016.02.007. Epub 2016 Mar 16.

    PMID: 26994597RESULT

  • Ajram J, Khalil I, Gergi R, Zogheib C. Management of an Immature Necrotic Permanent Molar with Apical Periodontitis Treated by Regenerative Endodontic Protocol Using Calcium Hydroxide and MM-MTA: A Case Report with Two Years Follow Up. Dent J (Basel). 2019 Jan 1;7(1):1. doi: 10.3390/dj7010001.

    PMID: 30609673RESULT

  • Khetarpal A, Chaudhary S, Talwar S, Verma M. Endodontic management of open apex using Biodentine as a novel apical matrix. Indian J Dent Res. 2014 Jul-Aug;25(4):513-6. doi: 10.4103/0970-9290.142555.

    PMID: 25307919RESULT

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

tricalcium silicatePemetrexed

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Chaza Kouchaji, Professor

    supervisal

    STUDY DIRECTOR

  • Thuraya Lazkani, Professor

    co-supervisal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple Masking: Patients, Investigators and Statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 9, 2023

Study Start

January 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)