Postoperative Pain and Success Rate in Pulpotomy Versus Root Canal Treatment

Pulpitis - Irreversible Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03916900
• Other study ID #: 14422017490583
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: Aya A Elsayed, BDS
• Phone: 00201090802757
• Email: aya.alaa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Pulpotomy
Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills
• Root canal treatment
Root canal treatment is an often straightforward procedure to relieve dental pain and save teeth. Patients typically need a root canal when there is inflammation or infection in the roots of a tooth. During root canal treatment, an endodontist who specializes in such treatment carefully removes the pulp inside the tooth, cleans, disinfects and shapes the root canals, and places a filling to seal the space.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain: VAS (visual analogue scale)	Postoperative pain reported by the patient after pulpotomy and root canal treatment by VAS (visual analogue scale).Scale from 0-10 recorded every 24hours until the fourth day. The VAS for pain is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable	4 days postoperatively
Secondary	Swelling, sinus or fistula	They will be assessed by visual examination.(Binary)	9 months
Secondary	Pain on percussion	It will be assessed by percussion test .(Binary)	9 months
Secondary	Radiographic success	It is defined as absence of inter-radicular or periapical radiolucency, widening of PDL space, internal or external root resorption).It will be assessed by periapical radiograph. parallel technique. Interpretation by Cohen's Kappa will be calculated.	9 months