Pulpotomy Clinical Trial
Official title:
Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars
Objective: To compare success rates of biodentine partial pulpotomy versus formocresol
pulpotomy treatment of pulpally exposed lower primary molars.
After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated
to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained,
an assistant drew lots to randomly allocate the case to either the biodentine partial
pulpotomy (PP) or the formocresol pulpotomy (FP) group.
The follow-up for clinical and radiographic evaluation will be carried out at 6-month
intervals.
- Prospective
- Study population: 100 patients.
- Study group: This study sample comprises mandibular primary molars from boys and girls
aged between 3 and 7 years. The children have no systemic diseases according to the
medical history supplied by the parents or guardians. The mandibular primary molars in
this study are selected according to the following clinical and radiographic criteria.
The clinical criteria: the presence of a deep carious lesion, sufficient tooth structure
for restoration with a stainless steel crown, no history of spontaneous pain, tenderness
to percussion or abnormal mobility, abscess, fistula, or swelling of the gingiva, and
with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure
was amputated. The radiographic criteria: a deep carious lesion in close proximity to
the pulp without furcation or radicular pathology, obliteration of the pulp and root
canal, or internal or external root resorption. Physiologic root resorption, while
included in the criteria, could not be more than one-third of the root length.
- Clinical technique: All teeth will be treated under local anaesthesia with rubber dam
isolation. After caries removal resulted in a pulp exposure, the pulp at the exposed
area is amputated to a depth of 2 mm using a water-cooled high-speed handpiece with a
#330 high-speed bur. The wound surface is irrigated with sterile saline solution and
dried with cotton pellets to avoid clot formation. After homeostasis is obtained, an
assistant drew lots to randomly allocate the case to either the PP or the FP treatment
group. The child will not know which treatment is assigned to each tooth. For the PP
group, biodentine is gently applied to the wound surface, and then covered with
reinforced zinc oxide-eugenol (IRM_; Dentsply). For the FP group, coronal access is
obtained using high-speed handpiece with a #330 high-speed bur with water spray to
further expose the pulp chamber. Following removal of the coronal pulp and achievement
of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is
placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM. After PP
or FP treatment, all teeth are restored with a stainless steel crown.
- Follow-up: the follow-up for clinical and radiographic evaluation will be carried out at
6-month intervals. Treatment is considered a clinical failure if one or more of the
following signs are observed: pain, abscess or sinus opening, tenderness upon
percussion, or abnormal tooth mobility. For radiographic evaluation, the treatment is
rated as a failure when one or more of the following signs are present: furcation or
periapical radiolucency, pathologic external root resorption, or internal resorption.
The treatment is regarded successful if both the clinical and radiographic evaluation
does not indicate any signs of failure.
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