Biodentine as an Apical Plug in Immature Permanent Molars
Primary Purpose
Periapical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Biodentine
MTA
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Periodontitis focused on measuring Apexification, MTA, Biodentine, Immature molars
Eligibility Criteria
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.
Sites / Locations
- College of dentistry.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Biodentine Group
MTA Group
Arm Description
study group
control group
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Change in the apical lesion healing speed
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
Change in the periapical index (PAI)
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).
Full Information
NCT ID
NCT05719987
First Posted
February 10, 2022
Last Updated
February 12, 2023
Sponsor
Damascus University
1. Study Identification
Unique Protocol Identification Number
NCT05719987
Brief Title
Biodentine as an Apical Plug in Immature Permanent Molars
Official Title
Effect of Biodentine Application as an Apical Plug on the Healing of Apical Lesions on Immature Permanent Molars.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
Apexification, MTA, Biodentine, Immature molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple Masking: Patients, Investigators and Statistician
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodentine Group
Arm Type
Experimental
Arm Description
study group
Arm Title
MTA Group
Arm Type
Other
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
Biodentine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MTA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the apical lesion size
Description
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
Time Frame
after 1,3,6 and 12 months of root canal obturation
Title
Change in the clinical assessment of success
Description
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.
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months of root canal obturation
Secondary Outcome Measure Information:
Title
Change in the apical lesion healing speed
Description
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
Time Frame
after 1,3,6 and 12 months of root canal obturation
Title
Change in the periapical index (PAI)
Description
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).
Time Frame
after 1,3,6 and 12 months of root canal obturation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaza Kouchaji, Professor
Organizational Affiliation
supervisal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thuraya Lazkani, Professor
Organizational Affiliation
co-supervisal
Official's Role
Study Director
Facility Information:
Facility Name
College of dentistry.
City
Damascus
State/Province
Al-Mazzeh Saint
ZIP/Postal Code
Damascus P.O.Box 3062
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17403040
Citation
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.
Results Reference
background
PubMed Identifier
31397907
Citation
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.
Results Reference
result
PubMed Identifier
33572890
Citation
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.
Results Reference
result
PubMed Identifier
26994597
Citation
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.
Results Reference
result
PubMed Identifier
30609673
Citation
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.
Results Reference
result
PubMed Identifier
25307919
Citation
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.
Results Reference
result
Learn more about this trial
Biodentine as an Apical Plug in Immature Permanent Molars
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