Postoperative Pain and Success Rate in Pulpotomy Versus Root Canal Treatment

NCT03916900 | Unknown

• 1 other identifier: 14422017490583
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Pulpitis - Irreversible

Keywords

Pulpotomy; Root canal treatment; Mature; Cariously exposed; Permanent molars; Irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Swelling, sinus or fistula

  9 months

• Pain on percussion

  9 months

• Radiographic success

  9 months

Study Arms (2)

Pulpotomy

EXPERIMENTAL

Group A (Experimental group) Pulpotomy: The teeth will be anesthetized with 4% articaine 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall, Spain) by inferior alveolar nerve block.Under rubber dam isolation, pulpotomy will be performed with a large sterile round end bur in a high speed hand piece with copious irrigation; pulp tissue will be removed by a sharp spoon excavator to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet moistened with 2.5% NaOCL for 2 min and repeated if needed. After hemostasis, Biodentine (Septodont, Saint Maur des Fausses, France) will be mixed according to the manufacturer's instructions and gently placed over the pulp to thickness of 2-3 mm.Biodentine will be covered by resin modified glass-ionomer and teeth will be restored using composite resin.A postoperative radiograph will be taken by parallel technique.

Procedure: Pulpotomy

Root canal treatment

ACTIVE COMPARATOR

Group B (control group) Root canal treatment: The teeth were anesthetized with 4% articaine 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall, Spain).Under rubber dam isolation, root canal treatment will be performed in single visit.Working length will be determined using stainless steel k-files (Mani, Inc.) keeping 0.5 to 1.0 mm short of the apex using a RootZX apex locator (J. Morita, Irvine, CA) and confirmed radiographically. Mechanical preparation will be achieved by a crown-down technique using using the M-PRO system (IMD, Shanghai, China) and irrigation with 5 mL 2.5% NaOCl between instruments.Obturation will be done with gutta-percha (Meta Biomed Co. Ltd, Cheongwongun, Chungbuk, Korea) and resin sealer ADseal (Meta Biomed CO., LTD, Korea) using cold lateral condensation technique and restored with composite resin with a base of glass-ionomer cement. A postoperative radiograph will be taken by parallel technique.

Procedure: Root canal treatment

Interventions

Pulpotomy PROCEDURE

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

Pulpotomy

Root canal treatment PROCEDURE

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.

Root canal treatment

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Central Study Contacts

Aya A Elsayed, BDS

CONTACT

00201090802757; aya.alaa@dentistry.cu.edu.eg

Aya A Abdelaziz, BDS

CONTACT

00201090802757; aya.alaa@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel assignment

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 9 months after completion of the study
• Access Criteria: ClinicalTrials.gov