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PulpotomyPhase 2NCT03786302

Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth

A Phase 2 study testing TAMP bioglass and Biodentine in people with Pulpotomy, run by Nourhan M.Aly at 1 site in Egypt.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth. Read more about this study

Who is it for?
Ages 5 to 9 years
Conditions the study is for
Pulpotomy
What is being tested?
TAMP bioglass and Biodentine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteEgypt
Study dates
6 Dec 2016to 20 Oct 2018
Phase
Phase 2
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 5 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children free of any systemic disease or special health care needs.
  • Children not receiving any anti-inflammatory medication.
  • Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
  • Restorable teeth.
  • Teeth with vital carious pulp exposure that will bleed upon entering the pulp chamber and not requiring more than 5 minutes to achieve hemostasis after coronal pulp amputation.
  • Teeth indicated for extraction for orthodontic purposes with the previously mentioned criteria (required for a subgroup for assessment of histological and inflammatory response outcomes).

Who cannot join

  • Teeth with clinical or radiographic signs of pulp degeneration.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentistry, Alexandria University

    Alexandria, 21512

Other trials in Egypt

About this study

Official title: Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth

The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth.

Read the detailed description

The study was a parallel design, randomized controlled clinical trial It was conducted in the out-patient clinic of the Pediatric Dentistry and Dental public health department after obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical considerations after showing significant clinical failure in the TAMP-BG group and after performing interim analysis.

Conditions
Pulpotomy
Being tested
TAMP bioglass, Biodentine
Keywords
TAMP BG, Biodentine, Regenerative materials, pulp therapy

What participants receive

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

  • TAMP bioglassDrug

    Also called 70S30C bioglass

    TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth

  • BiodentineDrug

    TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth

Study groups in NCT03786302
Study groupRoleWhat they receive
TAMP bioglassExperimentalTailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps.
Receives: Drug: TAMP bioglass
Biodentine ™Active comparatorBiodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set.
Receives: Drug: Biodentine

What is being measured

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

  1. Absence of clinical signs of pulp degeneration.

    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

    Measured: 1 month postoperatively

  2. Percentage of Teeth with no clinical signs of pulp degeneration.

    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

    Measured: 3 months postoperatively

  3. Percentage of Teeth with no clinical signs of pulp degeneration.

    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

    Measured: 6 months postoperatively

  4. Percentage of Teeth with no clinical signs of pulp degeneration.

    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

    Measured: 9 months postoperatively

  5. Percentage of Teeth with no clinical signs of pulp degeneration.

    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

    Measured: 12 months postoperatively

  6. Percentage of Teeth with no radiographic signs of pulp degeneration.

    Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening

    Measured: 6 months postoperatively

  7. Percentage of Teeth with no radiographic signs of pulp degeneration.

    Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening

    Measured: 12 months postoperatively

Secondary outcomes (5)

  1. Percentage of teeth with radiographic evidence of dentin bridge formation

    Assessed using digital radiographs

    Measured: 6 months postoperatively

  2. Percentage of teeth with radiographic evidence of dentin bridge formation

    Assessed using digital radiographs

    Measured: 12 months postoperatively

  3. Dentin bridge formation using light microscopy

    After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria.

    0= No hard tissue formation.

    1. Incomplete hard tissue formation.
    2. Thick hard tissue formation.

    Measured: 6 weeks

  4. Inflammatory response using light microscopy

    After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. A. Inflammatory cell response:

    0= None or a few scattered inflammatory cells beneath the site of pulp exposure.

    1. Mild inflammatory cells (either acute or chronic).
    2. Moderate inflammatory cell infiltration involving the cervical third of radicular pulp.
    3. Severe inflammatory cell infiltration involving the coronal third of radicular pulp.
    4. Tissue disorganization:

    0= Normal tissue beneath the site of pulp exposure.

    1. Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization.
    2. General disorganization of the pulp tissue pattern.
    3. Pulp necrosis.

    Measured: 6 weeks

  5. The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.

    After extraction, the tooth will be sectioned under copious water cooling and all remaining pulp tissue will be harvested gently from the radicular portion and stored until the time of assaying. For the ELISA assaying, the frozen pulp samples will be thawed for 15 minutes, and crushed with a glass rod in the eppendorf tube to elute the cytokines from the pulp tissue. IL-8 and IL-10 will be measured using ElISA Kits according to the instructions supplied with the kit and the ratio of IL-8/IL-10 will be taken as an indicator of pulpal inflammation. Cytokines' concentration will be calculated according to the weight of the pulp tissue.

    Measured: 6 weeks

Timeline

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

  1. First posted26 Dec 2018
  2. Study start6 Dec 2016
  3. Primary completion15 Aug 2018
  4. Study completion20 Oct 2018

Why it stopped: Failure rate was 100% in one arm of the study (the intervention)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03786302
Sponsor's protocol ID
Bioglass in pulpotomized teeth
Status last verified
Oct 2020
First submitted
18 Dec 2018
Last updated
14 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang S, Falk MM, Rashad A, Saad MM, Marques AC, Almeida RM, Marei MK, Jain H. Evaluation of 3D nano-macro porous bioactive glass scaffold for hard tissue engineering. J Mater Sci Mater Med. 2011 May;22(5):1195-203. doi: 10.1007/s10856-011-4297-4. Epub 2011 Mar 29.

    PubMed 21445655

  • Wang S, Kowal TJ, Marei MK, Falk MM, Jain H. Nanoporosity significantly enhances the biological performance of engineered glass tissue scaffolds. Tissue Eng Part A. 2013 Jul;19(13-14):1632-40. doi: 10.1089/ten.TEA.2012.0585. Epub 2013 Mar 26.

    PubMed 23427819

  • Stanley HR, Clark AE, Pameijer CH, Louw NP. Pulp capping with a modified bioglass formula (#A68-modified). Am J Dent. 2001 Aug;14(4):227-32.

    PubMed 11699742

  • Horsted P, El Attar K, Langeland K. Capping of monkey pulps with Dycal and a Ca-eugenol cement. Oral Surg Oral Med Oral Pathol. 1981 Nov;52(5):531-53. doi: 10.1016/0030-4220(81)90366-2.

    PubMed 6946381

  • Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.

    PubMed 23265156

  • Elhamouly Y, El Backly RM, Talaat DM, Omar SS, El Tantawi M, Dowidar KML. Tailored 70S30C Bioactive glass induces severe inflammation as pulpotomy agent in primary teeth: an interim analysis of a randomised controlled trial. Clin Oral Investig. 2021 Jun;25(6):3775-3787. doi: 10.1007/s00784-020-03707-5. Epub 2021 Jan 6.

    PubMed 33409691

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAMP bioglass and Biodentine in people with Pulpotomy, run by Nourhan M.Aly at 1 site in Egypt.

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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Oct 2020. 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 Egypt. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Failure rate was 100% in one arm of the study (the intervention)). Results are not available in the source record.

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?

Absence of clinical signs of pulp degeneration. (time frame: 1 month postoperatively). The study lists 7 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 NCT03786302, 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 Oct 2020.

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