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Periapical PeriodontitisNCT05719987

Biodentine as an Apical Plug in Immature Permanent Molars

A study testing Biodentine and MTA in people with Periapical Periodontitis, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 9 years
Conditions the study is for
Periapical Periodontitis
What is being tested?
Biodentine and MTA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSyria
Study dates
1 Jan 2020to 30 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Syria1 site
  • College of dentistry.

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

Other trials in Syria

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Biodentine, MTA
Keywords
Apexification, MTA, Biodentine, Immature molars
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT05719987
Study groupRoleWhat they receive
Biodentine GroupExperimentalstudy group
Receives: Other: Biodentine
MTA GroupOthercontrol group
Receives: Other: MTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (2)
  1. 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

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

  2. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start1 Jan 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05719987
Sponsor's protocol ID
UDDS-Pedo-12-2016
Status last verified
Feb 2023
First submitted
10 Feb 2022
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17403040
  • 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.

    PubMed 31397907
  • 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.

    PubMed 33572890
  • 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.

    PubMed 26994597
  • 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.

    PubMed 30609673
  • 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.

    PubMed 25307919

Questions about this trial

What is this clinical trial studying?

A study testing Biodentine and MTA in people with Periapical Periodontitis, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the apical lesion size (time frame: after 1,3,6 and 12 months of root canal obturation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05719987, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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