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Irreversible PulpitisNCT04243733

MTA vs CEM Pulpotomy in Young Permanent Molars

A study testing CEM and MTA and MTA and CEM in people with Irreversible Pulpitis, run by Suez Canal University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study The purpose of this present clinical study will be to assess : " the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis . Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Irreversible Pulpitis
What is being tested?
CEM and MTA and MTA and CEM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
10 Oct 2018to 10 Jan 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 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Clinical examination reveals extended carious lesion on the molar teeth surface not extending toward the root. All of the patients report a history of pain typical of irreversible pulpitis ie; the chief complaints are of spontaneous pain lasting from a few seconds to several hours in the days before consultation. This radiating pain is exacerbated by hot and cold fluids and require analgesia for pain relief. The pain does not abate following tooth brushing or flossing. All of the parents are willing to join the study. All teeth are believed to be vital and the vitality of all the subjected molar teeth was checked by the operator during the pulpotomy procedure through visual inspection of pulpal hemorrhage.

Who cannot join

  • Clinical examination reveals extended carious lesion on the molar teeth surfaces not extending toward the root. All of the patients report a history of pain typical of irreversible pulpitis ie; the chief complaints are of spontaneous pain lasting from a few seconds to several hours in the days before consultation. This radiating pain is exacerbated by hot and cold fluids and require analgesia for pain relief. The pain does not abate following tooth brushing or flossing. All of the parents are willing to join the study. All teeth are believed to be vital and the vitality of all the subjected molar teeth was checked by the operator during the pulpotomy procedure through visual inspection of pulpal hemorrhage.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Marwa

    Ismailia

    marwa e sharaan, PhD, 01000984071, marwaelsayedsharaan@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: MTA vs CEM Pulpotomy in Young Permanent Molars With a Diagnosis of Irreversible Pulpitis: A Randomized Clinical Trial

The aim of the study

The purpose of this present clinical study will be to assess :

" the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis .

" the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis.

Read the detailed description

Introduction and Review of Literature

Partial pulpotomy is generally regarded as the treatment of choice for immature teeth with exposed. pulp tissue. This treatment preserves pulp function,thus allowing continued root development . It was reported that 96% of teeth healed after being treated with partial pulpotomies associated with complicated crown fractures. This technique consists of the surgical amputation of 2-3mm of inflamed coronal pulp tissue. The wound surface is treated with a capping agent to promote healing and maintain viability of the remaining pulp tissue. It has been suggested that partial pulpotomy, compared with cervical pulpotomy, has many advantages including preservation of the cell-rich coronal pulp tissue, a necessary element for better healing , and the physiologic apposition of dentine in the coronal area. In contrast, cervical pulpotomy removes all the coronal pulp tissue, leaving the crown without the possibility of physiologic apposition of dentine, thereby increasing the risk of cervical fracture. Vital pulp treatment with materials such as mineral trioxide aggregate (MTA) are explored in studies on new trends in dental biomaterials .The successful use of MTA has been reported for partial pulpotomy of caries-exposed immature permanent teeth 5 and permanent teeth with irreversible pulpitits. On the other hand MTA possess some disadvantages; the most important one is its cost.

Calcium-enriched mixture (CEM, BioniqueDent, Tehran, Iran) cement has been introduced as a new endodontic biomaterial .This water-based tooth-colored cement is a biocompatible mixture cement that releases calcium and phosphate ions to form hydroxyapatite to induce the formation of a dentinal bridge.The product is alkaline (pH > 10.5) and releases calcium hydroxide during and after setting.The clinical use of CEM cement is similar to that of MTA. As a result, the characteristics of this cement are compared with MTA in some studies, showing a shorter setting and working time for CEM as well as a lower film thickness. CEM cement also shows a superior antibacterial effect 12 and improved handling 10. Both have similar sealing ability. The stated advantages of CEM cement and its potential effect on healing of the remaining pulp and the induction of dentinal bridge formation have led researchers to recommend use of the material in pulp treatment procedures in permanent teeth such as indirect and direct pulp cap, pulpotomy 13-17 and root-end fillings 18.One of the benefits of CEM cement is in the treatment of permanent teeth associated with irreversible pulpitis. The results of some clinical studies suggest vital pulp therapy with CEM as an alternative treatment to root canal therapy in such case with irreversible pulpitis.

To date, few studies have compared CEM cement and MTA as dressing materials for direct pulp cap and pulpotomy in young permanent molar teeth. The purpose of this present clinical study will be to assess the effect of CEM cement in the pulpotomy of young permanent molar teeth with irreversible pulpitis.

The aim of the study

The purpose of this present clinical study will be to assess :

" the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis .

" the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis.

Materials and methods This is a double-blind, randomized, and con- trolled clinical trial. Forty children will be assigned randomly into two groups (20 children each) by block randomization, and allocation concealment will be done with closed envelop method. The sample size was obtained by using the G* power software statistical analysis according to previous studies. The research protocol will be approved by the Human Ethics Review Committee of the Faculty of Dentistry, Suez Canal University. For this 1-year clinical study, patients aged 6-14 years will be selected from the endodontic and pedodontic Clinics in the University. All of the parents will be told about the study and signed the informed consent.

Inclusion Criteria: Clinical examination reveals extended carious lesion on the molar teeth surface not extending toward the root. All of the patients report a history of pain typical of irreversible pulpitis ie; the chief complaints are of spontaneous pain lasting from a few seconds to several hours in the days before consultation. This radiating pain is exacerbated by hot and cold fluids and require analgesia for pain relief. The pain does not abate following tooth brushing or flossing. All of the parents are willing to join the study. All teeth are believed to be vital and the vitality of all the subjected molar teeth was checked by the operator during the pulpotomy procedure through visual inspection of pulpal hemorrhage.

Exclusion Criteria: Patients with systemic disease or physical or mental disability, extremely poor oral hygiene, periodontal problems, signs of abscess or fistula or non-physiological tooth mobility and non-restorable teeth will be excluded from the study. Teeth with external or internal root canal resorption, or root canal calcification in pre-treatment radiographs will be also excluded. Teeth where hemostasis can not be achieved will be excluded.

Pulpotomy Procedure: The treatment procedure will be performed after obtaining adequate local anesthesia with 2% lidocaine and 1/80,000 epinephrine ,the surface of the tooth was rinsed with normal saline and cleaned by swab wetted by a 0.2% chlorhexidine oral rinse . Pulpotomy procedures will be then performed with rubber dam then will be followed by complete removal of caries using fissure diamond burs and round stainless-steel burs. Pulpotomy will be performed with a sterile round diamond bur on a high-speed headpiece with copious water to remove all of the inflamed pulpal tissue. Following pulp amputation, the pulp chamber will be irrigated using 5% sodium hypochlorite until homeostasis is obtained. Teeth where hemostasis can not be achieved were excluded.

The CEM powder and liquid or MTA powder will be mixed according to the manufacturer's instruction and a base of approximately 2 mm of CEM cement will be placed over the amputation site. A wet cotton pellet will be used for adaption of the cement to the tooth walls. After 1 week the patient will be recalled for final restoration of the tooth with amalgam or a stainless steel crown. Prior to tooth restoration, the operator checks that the patient has no pain or clinical problems (ie; tenderness to percussion, swelling, fistula or mobility due to disease). A recall program is arranged for all patients and all of the teeth are evaluated clinically and radiographically.

Clinical Assessment: Clinical success is reviewed at 7 days and 3, 6 and 12 months after treatment. The teeth are tested for tenderness to percussion, soft tissue redness, dental swelling, abscess and fistula indicating any extension of inflammation toward the root canals. The parents are supplied with a telephone number so that they can inform the dentist of any problems.

Radiographic Assessment: No internal or external root resorption, no loss of lamina dura integrity, no periodontal ligament widening, and no alveolar bone resorption in the periapical region are considered indicative of successful treatment.

The clinical and radiographic assessments are all performed by the same two calibrated dentists. Where there initial is disagreement, consensus evaluations are performed by the two examiners.

Being tested
CEM and MTA, MTA and CEM

What participants receive

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

  • CEM and MTAOther

    Pulpotomy agent

  • MTA and CEMOther

    Pulpotomy agent

Study groups in NCT04243733
Study groupRoleWhat they receive
calcium enriched mixture material (CEM)OtherUsing CEM as a pulpotomy agent against MTA pulpotomy agent.
Receives: Other: CEM and MTA; Other: MTA and CEM
Mineral trioxide aggregate material (MTA)ExperimentalUsing MTA as a pulpotomy agent against CEM pulpotomy agent.
Receives: Other: CEM and MTA; Other: MTA and CEM

What is being measured

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

  1. the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis .

    clinical signs and symptoms and testing sensibility of the pulp by cold test

    Measured: one year follow up after starting the case

  2. the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis.

    healing of apical radiolucency, no occurrence of apical radiolucency

    Measured: one year follow up after starting the case

Timeline

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

  1. First posted28 Jan 2020
  2. Study start10 Oct 2018
  3. Primary completion10 Dec 2020 (estimated)
  4. Study completion10 Jan 2021 (estimated)

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04243733
Sponsor's protocol ID
110/2018
Status last verified
Jan 2020
First submitted
21 Dec 2019
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • References: [1] Smaïl-Faugeron V, Courson F, Durieux P, Muller-Bolla M, Glenny AM, Fron Chabouis H. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev 2014; 8(8): CD003220. [2] Tannure PN, Azevedo CP, Barcelos R, Gleiser R, Primo LG. Long-term outcomes of primary tooth pulpectomy with and without smear layer removal: a randomized split-mouth clinical trial. Pediatr Dent 2011; 33(4): 316-20. [3] Barcelos R, Tannure PN, Gleiser R, Luiz RR, Primo LG. The influence of smear layer removal on primary tooth pulpectomy outcome: a 24-month, double-blind, randomized, and controlled clinical trial evaluation. Int J Paediatr Dent 2012; 22(5): 369-81. [4] McDougal RA, Delano EO, Caplan D, Sigurdsson A, Trope M. Success of an alternative for interim management of irreversible pulpitis. J Am Dent Assoc 2004; 135(12): 1707-12. [5] Barrieshi-Nusair KM, Qudeimat MA. A prospective clinical study of mineral trioxide aggregate for partial pulpotomy in cariously exposed permanent teeth. J Endod 2006; 32(8): 731-5. [6] Eghbal MJ, Asgary S, Baglue RA, Parirokh M, Ghoddusi J. MTA pulpotomy of human permanent molars with irreversible pulpitis. Aust Endod J 2009; 35(1): 4-8. [7] Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent 2005; 27(2): 129-36. [8] Noorollahian H. Comparison of mineral trioxide aggregate and formocresol as pulp medicaments for pulpotomies in primary molars. Br Dent J 2008; 204(11): E20. [9] Simancas-Pallares MA, Díaz-Caballero AJ, Luna-Ricardo LM. Mineral trioxide aggregate in primary teeth pulpotomy. A systematic literature review. Med Oral Patol Oral Cir Bucal 2010; 1(15): e 942-6. [10] Asgary S, Shahabi S, Jafarzadeh T, Amini S, Kheirieh S. The properties of a new endodontic material. J Endod 2008; 34(8): 990-3. [11] Amini Ghazvini S, Abdo Tabrizi M, Kobarfard F, Akbarzadeh Baghban A, Asgary S. Ion release and pH of a new endodontic cement, MTA and Portland cement. Iran Endod J 2009; 4(2): 74-8] [12] Asgary S, Kamrani FA. Antibacterial effects of five different root canal sealing materials. J Oral Sci 2008; 50(4): 469-74. [13] Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand 2013; 71(1): 130-6. [14] Asgary S, Eghbal MJ, Ghoddusi J, Yazdani S. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial. Clin Oral Investig 2013; 17(2): 431-9. [15] Tabarsi B, Parirokh M, Eghbal MJ, Haghdoost AA, Torabzadeh H, Asgary S. A comparative study of dental pulp response to several pulpotomy agents. Int Endod J 2010; 43(7): 565-71. [16] Nosrat A, Asgary S. Apexogenesis of a symptomatic molar with calcium enriched mixture. Int Endod J 2010; 43(10): 940-4. [17] Nosrat A, Seifi A, Asgary S. Pulpotomy in caries-exposed immature permanent molars using calcium-enriched mixture cement or mineral trioxide aggregate: a randomized clinical trial. Int J Paediatr Dent 2013; 23(1): 56-63. [18] Asgary S, Eghbal MJ, Ehsani S. Periradicular regeneration after endodontic surgery with calcium-enriched mixture cement in dogs. J Endod 2010; 36(5): 837-41. [19] Asgary S, Eghbal MJ. The effect of pulpotomy using a calcium-enriched mixture cement versus one-visit root canal therapy on postoperative pain relief in irreversible pulpitis: a randomized clinical trial. Odontology 2010; 98(2): 126-33. [20] Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods 2007; 39(2): 175-91.

Questions about this trial

What is this clinical trial studying?

A study testing CEM and MTA and MTA and CEM in people with Irreversible Pulpitis, run by Suez Canal University 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 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 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.

Are results available for this study?

Results are not available in the source record.

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

Contact marwa E Sharaan, PhD (00201000984071, marwaelsayedsharaan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis . (time frame: one year follow up after starting the case). 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 NCT04243733, which also lists 1 linked publication.

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 28 Jan 2020.

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