Clinical trial NCT04018456: Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
Official title: Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotic Pulp
Apical Periodontitis
Keywords: Necrotic pulp,
Apical periodontitis
Regeneration
MTA
Biodentine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

Detailed description: • Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.

Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.

At the end of treatment, the access cavity will be sealed with composite restoration.

Eligibility criteria: Inclusion Criteria:

1. Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
2. Negative response of pulp tissue to electrical or thermal pulp tester.
3. Widening in lamina dura or periapical radiolucency not more than 3 mm.

Exclusion Criteria:

* 1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.

  3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).

  4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration

Primary outcomes:
measure: Discoloration of teeth
timeFrame: Up to one Year after completion of regenerative endodontic treatment
Secondary outcomes:
measure: Healing of Periapical Tissue
timeFrame: after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
measure: Restoring the sensibility of tooth
timeFrame: after 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dentistry Faculty
Study officials:
affiliation: Cairo University
name: Amatallah HN Al-Rawhani, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.