Biodentine as an Apical Plug in Immature Permanent Molars

February 12, 2023 updated by: Damascus University

Effect of Biodentine Application as an Apical Plug on the Healing of Apical Lesions on Immature Permanent Molars.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following the randomization procedure, patients will be assigned sequential numbers in the order of enrolment. Group I will include 12 immature molars treated with MTA (White ProRoot MTA, Dentsply, Tulsa, OK, USA) as apical plug, whereas group II will include 12 immature molars treated with Biodentine (Septodont, Saint-Maur-des-Fosses, France) as apical plug. All the apexification treatments will be performed by the researcher. Under local anesthesia and rubber dam isolation, all superficial caries will be removed with carbide fissure bur mounted on a low-speed hand-piece. Access cavity will be prepared using an endo-z bur mounted on high-speed hand-piece, and the cavity will be rinsed with 2.5% NaOCl. Working length will be calculated radiographically with K-files (Mani, INK, Japan) and recorded as reference. root canals will be instrumented gently with Fanta AF3 (Fanta Dental Materials Co., LTD, Shanghai, China) and copious irrigation with 1.3% sodium hypochlorite (NaOCI) (Merck, Darmstadt, Germany) by a 30- gauge endodontic irrigating needle (Sybron Endo, Crop, Orange, CA, USA). As final irrigation all canals will be filled up with NaOCl 1.3% and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 30 seconds for each canal, then all canals will be irrigated with normal saline, then all canals will be filled up with Q-mix (Dentsply Tulsa Dental, Tulsa, OK, USA) and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 10 seconds. After drying with large sterile paper points apical plug will be done according to randomization MTA with 2 visits or Biodentine with one visit.

Biodentine Group (performed in a single clinic visit of approximately 45 minutes): Biodentine will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the Biodentine plugs will be verified with a radiograph. After 12 min the setting of Biodentine will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless-steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).

MTA Group (performed in 2 clinic visits, each visit will be approximately 30 minutes): MTA will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the MTA plugs will be verified with a radiograph. After inserting MTA, a moist cotton pellet will be placed in the canal, and the access cavity will be restored with temporary filling (TG, Germany). Next day, under local anesthesia and rubber dam isolation, the temporary filling and the cotton pellet will be removed and the setting of MTA will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).

Patients of both groups will be recalled for radiographical follow-up after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA) and intraoral sensor (VATECH. Gyeonggi-do, Korea) . The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using "Image J" program and scored in both groups blindly, independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached.

Patients of both groups will be recalled for clinical follow-up after the end of treatment at 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months to detect pain, swelling, tenderness to percussion, abscess, fistula, and abnormal tooth mobility Finally, the numerical data of the apical lesions sizes and ranked data of clinical variables will be statistically analyzed using SPSS, and any statistically significant values will be investigated.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
    • Al-Mazzeh Saint
      • Damascus, Al-Mazzeh Saint, Syrian Arab Republic, Damascus P.O.Box 3062
        • College of dentistry.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biodentine Group
study group
Other: Biodentine
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.
OTHER: MTA Group
control group
Other: MTA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the apical lesion size
Time Frame: after 1,3,6 and 12 months of root canal obturation

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
Time Frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months of root canal obturation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the apical lesion healing speed
Time Frame: after 1,3,6 and 12 months of root canal obturation
Apical lesion healing speed of MTA apical plugs and Biodentine apical plugs in necrotic immature permanent molars with apical lesions using "Image J" to determine the percentage of apical lesion reduction
after 1,3,6 and 12 months of root canal obturation
Change in the periapical index (PAI)
Time Frame: after 1,3,6 and 12 months of root canal obturation
Radio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).
after 1,3,6 and 12 months of root canal obturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Director: Thuraya Lazkani, Professor, co-supervisal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (ACTUAL)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-12-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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