Clinical Comparison of Vital Pulp Capping Restorative Protocols



Status:Active, not recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 64
Updated:10/13/2018
Start Date:June 2015
End Date:October 2019

Use our guide to learn which trials are right for you!

Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study

At present, dentistry aims for conservative treatments with the goal of maintaining as much
tooth structure as possible. Dental caries remains the most prevalent chronic disease
worldwide; these lesions can progress rapidly and reach deeper areas of the tooth. The
carious lesion is considered deep when it goes through the main tissues of the tooth, and it
can affect the pulp tissue, where the nerve and nutrients of the tooth are located. There are
many treatment options for deep carious lesions and they vary by the clinical scenario. Vital
pulp therapy has become a fairly predictable alternative treatment to pulpectomy (root canal
therapy). The goal of vital pulp capping therapies is to keep the pulp of the teeth vital to
prevent further interventions such as root canal treatments and complex restorative work.
There are two main clinical scenarios when treating these lesions, depending on the remaining
dentin thickness between the carious lesion and the pulp: vital direct and indirect pulp
capping. Direct and indirect vital pulp therapies are routinely performed using different
clinical protocols. The clinical protocols are selected based on the remaining dentin
(between the tooth preparation and pulp) and the restorative materials. There are few studies
that evaluate pulp capping method in adult teeth (permanent dentition); many studies have
investigated baby teeth (deciduous teeth). Routine therapies include the using of adhesive
restorations with and without an intermediate layer of restorative material. Calcium
hydroxide based cements have been used for pulp capping as an intermediate layer of
restorative material. More recently a new intermediate layer of restorative material composed
of resin-modified calcium silicate has been indicated for use on direct and indirect pulp
capping. The aims of this study are to compare, over a period of 12 months, the
post-operative sensitivity and pulp vitality of three indirect pulp capping protocols and two
direct pulp capping protocol in vital teeth. This study will provide the necessary evidence
to allow clinicians to select the best restorative protocol when treating deep carious
lesions where indirect and direct pulp capping protocol are needed.


Inclusion Criteria:

Clinical inclusion criteria:

- Adults in good general health between 18 and 64 years of age;

- Active carious lesions deep into dentin (75% or more of dentin) involving
occlusal/incisal and/or proximal surfaces of permanent teeth;

- Absence of clinical symptoms of irreversible pulpitis (spontaneous pain);

- Absence of periapical pathology, sinus tract, swelling or abnormal mobility;

- Restorable teeth.

Radiographic inclusion criteria:

- Extension of carious lesion close to potential exposure upon excavation (within the D3
region - lesion extending 2/3 within dentin); with the presence of a well-defined
radiodense zone between the lesion and the pulp;

- Absence of periapical radiolucency;

- Absence of thickening of the periodontal ligament PDL;

- Absence of resorptive defects.

Exclusion Criteria:

- Non restorable teeth;

- Teeth with:

- Recent trauma (within 6 months);

- Calcified root canals;

- Periapical radiolucency;

- Patients experiencing spontaneous moderate to severe pain;

- Patients that are pregnant or planning to become pregnant in the next year.

- Patients taking analgesics, anti-inflammatory, or antidepressant medications;

- Patients with orthodontic treatment;

- Newly erupted teeth.
We found this trial at
1
site
Chicago, Illinois 60612
Phone: 312-996-1553
?
mi
from
Chicago, IL
Click here to add this to my saved trials