Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01622153 |
| Other study ID # |
021117 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
June 14, 2012 |
| Last updated |
May 9, 2017 |
| Start date |
June 2011 |
| Est. completion date |
June 2014 |
Study information
| Verified date |
May 2017 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
1. The investigator hypothesize that the Laser pulpotomy will provide adequate and
comparable success clinically in primary molars.
2. The investigators hypothesize that the Laser pulpotomy will provide adequate and
comparable success radiographically in primary molars.
Description:
The health of teeth, their supporting tissues and maintaining their integrity is the primary
goal of pulp therapy. Conservative pulp therapy for primary teeth aims to maintain pulp
vitality, reduce the need for a pulpectomy, and promote the integrity and retention of such
teeth until appropriate exfoliation.(51) A pulpotomy is usually performed for carious
exposures of primary teeth with normal pulp or reversible coronal pulpitis, or primary teeth
pulpally exposed by trauma (AAPD 2009). A pulpotomy requires healthy radicular pulp capable
of healing after amputation of inflamed or infected coronal pulp [Fuks and Eidelman, 1991].
After the coronal pulp is amputated, the remaining vital radicular pulp tissue surface is
treated with a long-term clinically successful medicament such as Buckley's Solution of
formocresol. (46-52) Electrosurgery has also demonstrated success. (53) The coronal pulp
chamber is filled with zinc/oxide, eugenol, or other suitable base, and the tooth is
restored with a restoration that seals the tooth from microleakage. The most effective
long-term restoration has been shown to be a stainless steel crown.
When the coronal tissue is amputated, the remaining radicular tissue is judged to be vital
without suppuration, purulence, necrosis, or excessive hemorrhage that cannot be controlled
with a damp cotton pellet after several minutes. In addition to this, if there are no
radiographic signs of infection or pathologic resorption then a pulpotomy procedure is
indicated. (Camp JH, Fuks AB) Despite concerns of toxicity, mutagenicity and carcinogenicity
[Swenberg et al., 1980; Goldmacher and Thilly, 1983; Ranly and Horn, 1987], formocresol (FC)
remains a commonly used primary tooth pulpotomy medicament [Hingston et al., 2007]. Various
clinical and radiographic success rates (59-100%) have been reported [Mejare, 1979; Naik and
Hegde, 2005], attributed to intra-patient variations, clinician and assessor factors, FC
concentrations and application times, coronal seal, and study durations.
As technology continues to improve, it allows dentists to treat patients with greater
precision, meaning less pain and quicker healing. The diode laser is used in many different
dental procedures. It is most commonly used to perform soft-tissue surgery in the mouth. The
diode laser's high-energy beam kills bacteria, thus it is often used to sterilize areas of
the mouth before or during root canal procedures. (Laser-dentistry/diode-laser) The diode
laser represents a whole new way of thinking about dental care. Laser treatment is less
painful, more convenient, and more effective than many traditional dental treatments. A
study by Bahrololoomi Z, Moeintaghavi A, comparing FC and electrosurgery pulpotomy after
nine months of follow up found that clinical and radiographical success rates were 96% and
84% respectively in the electrosurgical group and 100% and 96.8% respectively in the
formocresol group. There was no statistical significance and the results showed that the
failure rates for electrosurgery pulpotomy were equal to those of formocresol pulpotomy.
Purpose:
Dental care has recently been identified as the most prevalent unmet health need amongst US
children (AAPD 2009). This research study investigates another treatment method to help
provide dental care to these children by evaluating the success rate of a laser (electrical)
pulpotomy compared to formocresol pulpotomy in primary molars with carious pulp exposure.
There is a need to study and assess the laser pulpotomy method in order to help create a
more efficient and painless treatment.
Study Design and Procedures:
We will perform a prospective study and clinical evaluation of patients ranging from ages
3-8 years old treated under general anesthesia from June, 2010 to June, 2014. The review and
analysis will be completed over a four year time period. The patients participating in this
study will include those presenting themselves as patients to the Tapper Pediatric Dentistry
clinic at Rainbow Babies Children's Hospital. These patients will only be scheduled to be
treated in the operating room when it is indicated as the best treatment option. Treatment
under General Anesthesia is indicated when: 1. Patient is uncooperative due to a lack of
psychological or emotional maturity and/or mental, physical, or medical disability. 2.
Patients for whom local anesthesia is ineffective because of acute infection, anatomic
variations, or allergy. 3. Extremely uncooperative, fearful, anxious, or uncommunicative
child or adolescent. 4. Patients requiring significant surgical procedures. 5. Patients for
whom the use of GA may protect the developing psyche and/or reduce medical risk. 6. Patients
requiring immediate, comprehensive oral/dental care (AAPD 2009). The patients will then be
consented and informed on the same day of the OR appointment. They will be given specific
post-op instructions both verbally and in written form. They will be scheduled for a
two-week follow-up appointment in the clinic following dental treatment. Informed consent
must be obtained by the parent/guardian of the patients that will participate in the study
and receive pulpotomy treatment with the laser technique. Other patients, regardless of the
study, will have pulpotomy treatment using the traditional formocresol technique.
All patients will receive general endotracheal anesthesia while receiving comprehensive
dental treatment. General anesthesia will be provided using a combination of inhaled
anesthetics and propofol intravenously. General anesthesia will be supplemented with
intravenous opioid analgesics, ketorolac unless contraindicated, and anti-mimetics. The
anesthetic approach will not be influenced by participation or non-participation of patients
in the study.
The patient's name, date of birth, and medical history will be obtained from each patient
chart. This PHI will be utilized to keep track of patient demographics for the study.
Patients scheduled for the operating room will be seen for a post-op two week follow up
appointment and regular dental visits regardless of whether or not they are participating in
the study.
Of the eligible subjects a randomized clinical trial will be performed on 90 primary molars
in children aged 3-8 years. Two preoperative bite wing radiographs will be taken. The teeth
will be treated for pulp therapy using either a conventional formocresol (30 controls and 30
study teeth) or GENTLEray 980 Soft Tissue diode laser (30 study teeth) technique. 30
Controls: The procedure for these 30 subjects is conducted using a #8 round diamond bur to
remove occlusal tooth structure for pulp chamber access and removal of coronal pulp. Cotton
pellets are saturated with conventional 1:5 dilution of Buckley's formocresol into the canal
orifice for 5 minutes for complete hemostasis. After this, a Chlorhexidine Gluconate 0.12%
rinse will be applied to decrease the bacterial level. Then, placement of 35% Phosphoric
Acid Etch for 15-30 seconds is rinsed off and dried until the tooth has a white, chalky
appearance. One layer of Optibond Solo is placed into the pulp chamber and light cured for
10 seconds with a 3M ESPE Elipar S10 light curing device. IRM (Zinc Oxide Eugenol) cement
will then be placed to seal the pulp chamber. A stainless steel crown will be cemented with
Ketac Cement that was triturated for 10 seconds to complete the pulpotomy procedure and
final restoration. 30 Conventional Formocresol: The procedure for these 30 subjects is
conducted using a #8 round diamond bur to remove occlusal tooth structure for pulp chamber
access and removal of coronal pulp. Cotton pellets are saturated with conventional 1:5
dilution of Buckley's formocresol into the canal orifice for 5 minutes for complete
hemostasis. After this, a Chlorhexidine Gluconate 0.12% rinse will be applied to decrease
the bacterial level. Then, placement of 35% Phosphoric Acid Etch for 15-30 seconds is rinsed
off and dried until the tooth has a white, chalky appearance. One layer of Optibond Solo is
placed into the pulp chamber and light cured for 10 seconds with a 3M ESPE Elipar S10 light
curing device. Dyract compomer will then be placed to seal the pulp chamber. A stainless
steel crown is cemented with Ketac Cement that was triturated for 10 seconds to complete the
pulpotomy procedure and final restoration. 30 Laser Diode: The procedure for these 30
subjects is conducted using a #8 round diamond bur to remove occlusal tooth structure for
pulp chamber access and removal of coronal pulp. Then a GENTLEray 980 Soft Tissue diode
laser (Power: 3.0W, Mode: PW, Fiber: 300µm, Ton: 100ms, Toff: 100ms, Timer: cont) will be
used to vaporize the residual pulp tissue and complete hemostasis. After completion of
hemostasis, a Chlorhexidine Gluconate 0.12% rinse will be applied to decrease the bacterial
presence. Subjects will then receive placement of 35% Phosphoric Acid Etch for 15-30 seconds
followed by 10 second light cured optibond solo. IRM (Zinc Oxide Eugenol) cement is then
placed to seal the pulp chamber. A stainless steel crown cemented with Ketac Cement for the
full coverage final restoration completes the pulpotomy procedure.
Following the pulpotomy procedures, the teeth will be evaluated for clinical and
radiographic success at 6 months post-op and 12 months post-op appointments at the Tapper
Pediatric Dental Clinic at Rainbow Babies Children's Hospital. The study teeth treated will
be evaluated clinically based on the presence of the following: (1) pain (2) abscess (3)
mobility. Radiographic success will be determined by evaluating a bite wing x-ray taken at
the two post-op appointments for the presence of the following: (1) internal resorption (2)
external resorption and (3) furcation radiolucency.
Risks:
The only physical risk in laser therapy is the risk of eye damage. While eye damage has not
been reported to date, we must still consider it as a possible risk. Because these study
subjects will be under General Anesthesia their eyes will already be closed and covered.
Suitable protective goggles should be worn by the investigator and assistants. Other
possible risks associated with this study include risks from anesthesia- (Nausea, vomiting,
epistaxis, fever, discomfort/pain). There are minimal to no risks involved in this research
study.
Benefits:
Pulpotomy treatment maintains the vitality of the tooth as well as the supporting tissues.
The longevity and prognosis of having a laser pulpotomy versus a formocresol pulpotomy
treatment has been considered to be just as beneficial. Through this research study, we can
further prove this new finding. Maintaining your primary dentition is extremely important
and this study will provide insight on how advances in dental technology can help better
treat carious teeth in more efficient and painless ways.
Alternatives:
Due to the nature of this research the only alternative is to not participate in this study.
