Clinical trial NCT03916900: Postoperative Pain and Success Rate in Pulpotomy Versus Root Canal Treatment
Official title: Evaluation of Postoperative Pain and Success Rate After Pulpotomy Versus Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Pulpotomy
Root canal treatment
Mature
Cariously exposed
Permanent molars
Irreversible pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 52
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Pulpotomy has been proposed in the last decade as a definitive treatment of mature permanent teeth with irreversible pulpitis due to the better understanding of the pulp biology and development of bioactive materials . This technique involves removal of the coronal portion of the pulp that has undergo degenerative and irreversible changes to the level of the canal orifices and leaving the healthy vital radicular portion of the pulp. The surrogate marker for the degree of inflammation and the healing potential of the remaining pulp tissue has been suggested to be the ability to control the bleeding after pulp amputation.

By preserving the pulp vitality, this can help in maintaining proprioceptive, reparative, innervation (tooth sensitivity), vascularization, and damping functions. The vital pulp can continue to serve the function of protecting the tooth from overload by means of protective feedback mechanism and preventing fracture because of the presence of pulp and organic tissue in the dentinal tubules..

Detailed description: The routine dental treatment for the patient diagnosed with symptomatic or asymptomatic irreversible pulpitis secondary to deep carious lesion is conventional root canal treatment. Root canal treatment is the preferred treatment option because of its superior success rate to other treatments .

However, it is expensive, time consuming and complicated. Root canal treatment needs special clinical skills and high socio-economic status to afford the cost of the treatment. Unfortunately, in developing countries these can be un-reachable. Therefore, extraction is the only alternative option to the affected teeth . Moreover, a recent systematic review by Ng et al stated that the success rate of root canal treatment had not improved over the past few decades and molars had poor survival rates in comparison to non-molar teeth.In addition, It was stated that the survival rate of endodontically treated tooth is alarmingly low in comparison to vital teeth, especially molars, During root canal treatment many mishaps can occur such as perforations, ledges and extrusion of root filling, that reduces the longevity of root treated teeth .

Carious pulp exposure of permanent molars in children is a very common unfortunate event faced in Pediatric Dentistry and Public Health department in Cairo university. This may be due to the low socioeconomic status, ignorance of patients attending that clinic, their wrong eating habits and their bad oral hygiene.

Root canal treatment in an uncooperative young patient is very complicated which may affect the quality and prognosis of the treatment itself. Therefore, an economical, simple and conservative technique such as pulpotomy should be considered Pulpotomy has been proposed in the last decade as a definitive treatment of mature permanent teeth with irreversible pulpitis due to the better understanding of the pulp biology and development of bioactive materials . This technique involves removal of the coronal portion of the pulp that has undergo degenerative and irreversible changes to the level of the canal orifices and leaving the healthy vital radicular portion of the pulp. The surrogate marker for the degree of inflammation and the healing potential of the remaining pulp tissue has been suggested to be the ability to control the bleeding after pulp amputation..

By preserving the pulp vitality, this can help in maintaining proprioceptive, reparative, innervation (tooth sensitivity), vascularization, and damping functions.The vital pulp can continue to serve the function of protecting the tooth from overload by means of protective feedback mechanism and preventing fracture because of the presence of pulp and organic tissue in the dentinal tubules.The dentin -pulp complex will stimulate the formation of tertiary dentine or a mineralized barrier protecting itself .

Compared to the root canal treatment, pulpotomy is considered less technique sensitive so it can be performed by general dental practitioners. Hence, It increases the patients' access to dental care and more clinicians will be able to provide the affordable treatment saving more teeth when the patients cannot afford the root canal treatment leaving extraction as a last treatment option.

It is believed that the pulp tissue of the younger aged patients has higher healing capacity and regenerative powers than pulp tissue in older aged patients.

Eligibility criteria: Inclusion Criteria:

* Children from 9 to 15 years, in good general health and medically free.
* Cariously exposed mature (complete root formation length and apical closure) permanent molars with reversible pulpitis, symptomatic or asymptomatic irreversible pulpits.
* Teeth should be vital on cold testing.
* Restorable teeth.
* Vital bleeding present in all canals.
* Hemostasis achieved after complete pulpotomy.
* Preoperative radiograph:Absence of periapical or inter-radicular radiolucency, widening of PDL space, internal or external root resorption.

Exclusion Criteria:

* Children with systemic diseases physical or mental disability, unable to attend follow-up visits or refuse participation.
* Previously accessed teeth.
* Necrotic teeth (negative response to cold testing or absence of bleeding after access cavity).
* Presence of sinus tract or swelling.
* Excessive bleeding after pulpotomy and not controlled after several minutes.
* Teeth with marginal periodontitis or crestal bone loss.

Primary outcomes:
measure: Postoperative pain: VAS (visual analogue scale)
timeFrame: 4 days postoperatively
Secondary outcomes:
measure: Swelling, sinus or fistula
timeFrame: 9 months
measure: Pain on percussion
timeFrame: 9 months
measure: Radiographic success
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References: