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Pulp NecrosisPhase 2/3NCT03849222

Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth

A Phase 2/3 study testing Apexification, MTA and Ca(OH)2 in people with Pulp Necrosis and Apexification, run by Al-Azhar University.

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

This study was conducted to evaluate the effect of the use of apical matrix, with Mineral Trioxide Aggregate (MTA) or calcium hydroxide Ca(OH)2 Apexification on apical healing and calcific barrier formation of immature teeth with non- vital pulp. Read more about this study

Who is it for?
Ages 8 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Pulp Necrosis, Apexification
What is being tested?
Apexification, MTA and Ca(OH)2
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
20 Aug 2013to 1 Sep 2016
Phase
Phase 2/3
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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Immature permanent maxillary anterior teeth
  • Non vital pulp
  • 6-18 years old
  • Half or more root length developed Restorable
  • No internal or external root resorption
  • No horizontal or vertical root fractures
  • Fit and healthy patient

Who cannot join

  • Mature
  • Vital pulp
  • <6 ,>18 years old
  • Less than half of the root developed
  • Non - restorable
  • Root resorption
  • Horizontal or vertical root fractures
  • Patients with history of uncontrolled diabetes, immunosuppression, severe asthma Patients suffering from periodontal disease

About this study

Official title: Enhancement of Apexification Procedure Outcome of Non Vital Incompletely Formed Roots Using Apical Matrix

This study was conducted to evaluate the effect of the use of apical matrix, with Mineral Trioxide Aggregate (MTA) or calcium hydroxide Ca(OH)2 Apexification on apical healing and calcific barrier formation of immature teeth with non- vital pulp.

Read the detailed description

Conventional root canal filling procedures are challenging in cases of teeth with necrotic pulp, immature apices, and periapical lesions because of the absence of natural apical constriction and the presence of moisture contamination. In these cases, the risk of extrusion of the root filling materials and the difficulty in managing apical seals compromise the long-term outcome of treatment.

Management of immature teeth with non-vital pulp were confined to custom fitting the filling material, paste fills and apical surgery. The limited success enjoyed by these procedures resulted in significant interest in the phenomenon of establishment of an apical barrier like apexification or continued apical development. Apexification defined as a procedure to induce a calcified barrier in a root with an open apex and necrotic pulp Traditionally, the most commonly used material for apexification is Ca(OH)2 .Despite the high success rate of The long-term Ca(OH)2 apexification , there are several disadvantages to this technique; Length of time for induction of apical hard tissue barriers. Incomplete apical hard tissue barriers because of vascular inclusions.To avoid the challenges associated with long-term Ca(OH)2 apexification procedures, a non-surgical, one-step apexification using MTA as apical plug.

The major problem in cases of a wide open apex is the need to limit the apexification material at the apex, thus avoiding the extrusion of a large amount of material into the periodontal tissue. The use of a matrix is advisable since its placement in the area of bone destruction provides a base on which the sealing material can be packed .

This randomized controlled trial study was carried out to compare the clinical and radiographic outcome of Ca(OH)2 and MTA with or without internal matrix in non-vital immature maxillary incisors.

Being tested
Apexification, MTA, Ca(OH)2, Apical matrix
Keywords
Open apex, Immature teeth, Non vital pulp, Apical plug, Internal matrix
Medical subject headings
Dental Pulp Necrosis

What participants receive

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

  • ApexificationProcedure or surgery

  • MTADrug

    Also called Proroot MTA

  • Ca(OH)2Drug

    Also called Ca(OH)2 dressing

  • Apical matrixDrug

    Also called internal matrix

    collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Study groups in NCT03849222
Study groupRoleWhat they receive
Ca(OH)2 ApexificationActive comparatorApexification was performed with calcium hydroxide. calcium hydroxide dressing was applied directly against the open apex .The canals were back filled with Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.
Receives: Procedure: Apexification; Drug: Ca(OH)2
Ca(OH)2 Apexification with apical matrixExperimentalTreated by condensation of calcium hydroxide dressing against an internal matrix , a piece (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy) was gently compacted toward the apex before insertion of Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.
Receives: Procedure: Apexification; Drug: Ca(OH)2; Drug: Apical matrix
MTA ApexificationActive comparatorApexification was performed with MTA as apical plug. A 3-5 mm thickness of MTA using a hand plugger was applied as apical plug and verified radiographically. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done
Receives: Procedure: Apexification; Drug: MTA
MTA Apexification with apical matrixExperimentalAn internal (apical) matrix was used as a base for condensation of MTA apical plug, a pieces of (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy)were compacted toward the apex with premeasured suitable size schilder plugger. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done
Receives: Procedure: Apexification; Drug: MTA; Drug: Apical matrix

What is being measured

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

  1. Change in pain on percussion

    Assessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome

    Measured: baseline, 3 months, 6 months, and 12 months

  2. Change in swelling and/or sinus

    Assessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no

    Measured: baseline, 3 months, 6 months, and 12 months

  3. Change in periapical pathosis

    Change in periapical bone density on follow up radiographs to assess the healing process

    Measured: 12 months

Secondary outcomes (2)

  1. presence of a calcified apical barrier or not

    Teeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation

    Measured: 3, 6 and 12 months

  2. Periapical Lesion scored with 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).baseline, 3 months, 6 months, and 12 months

    Measured: 12 months

Timeline

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

  1. First posted21 Feb 2019
  2. Study start20 Aug 2013
  3. Primary completion20 Apr 2016
  4. Study completion1 Sep 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
participants are allocated at random to receive one of 4 interventions according to the research plan.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03849222
Sponsor's protocol ID
REC 61
Status last verified
Feb 2019
First submitted
4 Jan 2019
Last updated
21 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Apexification, MTA and Ca(OH)2 in people with Pulp Necrosis and Apexification, run by Al-Azhar University.

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 7 inclusion and 8 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 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 pain on percussion (time frame: baseline, 3 months, 6 months, and 12 months). The study lists 3 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 NCT03849222.

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 21 Feb 2019.

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