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Completed

NCT Number: NCT03083015

Pulp Revascularization Versus MTA Apexification

This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.

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Key information

Conditions

Necrotic Pulp Dental Pulp Diseases Dental Pulp Necrosis Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.

Exclusion criteria

  • History of allergy to any of the antibiotics in the tri-mix used in the study
  • Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
  • Psychological disturbance
  • External / internal root resorption or cystic lesion.

Treatment and study plan

Revascularization

Procedure

a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process

Other names: regeneration

Apexification

Procedure

a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.

Primary outcomes

  1. Pain intensity measures

    Time frame: 2 days

    self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.

Secondary outcomes

  1. Resolution of periapical pathosis

    Time frame: 9 months

    Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.

  2. Amount of radiographic increase in root length:

    Time frame: baseline and 9 months

    Root length was measured as a straight line from the cement-enamel junction to the radiographic apex of the tooth in millimeters = (9months follow up length - baseline length)

  3. Amount of radiographic increase in the root dentinal wall thickness:

    Time frame: baseline and 9 months

    Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.

  4. Decrease of apical diameter:

    Time frame: baseline and 9 months

    the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements

Sponsors and collaborators

Lead sponsor

Enas Ebrahim Sayed

Other

Registry information

Official study title

A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial

Acronym: RCT

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2017
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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