Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05347160 |
| Other study ID # |
A04080920 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The management of permanent teeth with incomplete root development with compromised pulpal
integrity presents a unique challenge. The loss of pulpal vitality before the completion of
dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal
walls. Every attempt should be made to preserve the vitality of these immature teeth until
maturation has occured.
Description:
The management of permanent teeth with incomplete root development with compromised pulpal
integrity presents a unique challenge. The loss of pulpal vitality before the completion of
dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal
walls. Every attempt should be made to preserve the vitality of these immature teeth until
maturation has occured. (1)
Pulpotomy is a universally accepted treatment modality for pulp exposures in immature
permanent teeth to preserve the vitality of the radicular pulp and to ensure continued root
development. (2) Calcium Hydroxide has been the most commonly utilized pulpotomy agent for
vital pulp therapy. However, owing to disadvantages such as degradation over time, formation
of tunnel defects beneath dentinal bridges and poor sealing , it is slowly losing its
popularity as a first choice agent for pulpotomy. (3)
Vital pulp therapy procedures in permanent teeth with incomplete root development have
advanced in recent years. Despite Mineral trioxide aggregate has shown promising potential as
a pulpotomy agent , it has some drawbacks that include the presence of toxic elements in the
material composition (4) , higher cytotoxicity in its freshly mixed state (5)
,high pH during setting (6) , difficult handling characteristics (7) , long setting time (8)
, tooth discoloration (9) and high cost. (10)
Consequently, newer calcium silicate-based materials that retain the desirable properties of
original MTA but with easier handling and without tooth discoloration have been introduced .
Biodentine has several
advantages, as its good sealing ability, adequate compressive strength , a relatively short
initial setting time and the promotion of reparative dentin formation with a positive effect
on vital pulp cells. (11, 12)
Recently, Regenerative Medicine , especially at the molecular and cellular level has been
given great attention towards 'regeneration' instead of 'replacement' approaches. (13)
resulting in 'vital pulp therapy' and regenerative endodontics Concepts. (14) In such
treatments, clean environment is believed to be a necessity for further success.
Triple Antibiotic Paste (TAP) , is a combination of 3 antibiotics, ciprofloxacin ,
metronidazole and Minocycline is widely used to achieve a relatively aseptic environment in
the radicular space so that the tissue repair and healing can occur. (15)
Promising results have attracted endodontists and general dental practitioners to endodontic
regenerative procedures (ERPs). (16) which is considered as a form of a revolution in root
canal therapy. (17-19) Now, it has now been taken into account as an alternative method to
traditional calcium hydroxide-induced apexogenesis. (20-21)
Recently, the paste used in the regeneration and revascularization protocol. Studies have
shown that the paste can eliminate the root canal microorganisms by removing the diverse
groups of obligate and facultative gram-positive and gram-negative bacteria , providing an
environment for healing. (22,23)
Platelet-rich fibrin (PRF) is a recent innovation in dentistry that has been prepared and
used in 2001. (24) It is considered as an autologous healing biomaterial incorporating
leukocytes, platelets, and a wide range of key healing proteins in a dense fibrin matrix.
(25) PRF serves as a reservoir for the slow continuous release of growth factors that
influence and direct the processes of reparative dentinogenesis (26) . Huang et al (27)
investigated the effect of PRF on cultured primary dental pulp cells and concluded that PRF
can increase dental pulp cell proliferation and differentiation.
Growth factors included in PRF are mitogenic , chemotactic and angiogenic. Therefore, they
appear to be critical to the wound-healing process. PRF induces osteoblasts, gingival
fibroblasts, and periodontal ligament cells proliferation as a mitogen . Because of growth
factors concentrates, PRF promotes wound healing and regeneration which is used in various
disciplines of dentistry to repair and regenerate dental and oral tissues. (28-30)
PRF has anti-inflammatory effect and act as an immune regulation mode. It presented as a
perfect scaffold in revascularization of immature permanent teeth with necrotic pulps as it
enhances cellular proliferation and differentiation. (31,32)
However, there is a limited number of studies reporting on the success of vital pulp therapy
for Immature permanent molars. So, the present study will evaluate different pulpotomy
modalities used in Immature permanent molars.
