Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars

NCT04636450 | Unknown DMC

• 1 other identifier: ULA-2020-ODP-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the aim is to compare manual and rotatory pulpectomy techniques on 100 primary mandibular molars on children between the ages of 4 and 8 years. The plan is to conduct a randomized controlled trial with a 1:1 ratio for group allocation at a teaching university pediatric dentistry clinic between January 2021 and December 2021. Two manual systems, as well as two rotary systems, will be randomly assigned. The adult manual system used will be K-file and the adult rotary system will be K3. The pediatric manual system used in this study will be Kedo-SH, while the pediatric rotary system will be Kedo-S. The observed outcome measures in this study are the following: 1) instrumentation and filling time; 2) filling quality by radiographic evaluation; 3) postoperative pain levels using the visual analog scale at 12 and 24 hours; and 4) frequency of complications (e.g. fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency) after a 3-, 6-, 9-, and 12-month follow-up.

Conditions

Dental Pulp Disease

Keywords

Pulp therapy; Rotatory system; Primary mandibular molar; Dental pulp cavity

Outcome Measures

Primary Outcomes (5)

• Instrumentation time

  The time needed to shape the root canal.

  Minutes; intraoperative time.

• Obturation time

  Time needed to obturate the root canals.

  Minutes, intraoperative time.

• Filling quality

  Radiographic evaluation of the root canal filling.

  Immediately after surgical procedure.

• Postoperative pain

  Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).

  12 hours

• Postoperative pain

  Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).

  24 hours

Secondary Outcomes (4)

• Complications secondary to procedure

  3-months

• Complications secondary to procedure

  6-months

• Complications secondary to procedure

  9-months

• Complications secondary to procedure

  12-months

Study Arms (4)

Adult manual instrumentation

ACTIVE COMPARATOR

Primary mandibular molars who are treated with a manual pulpectomy and a K-file system.

Procedure: Manual pulpectomy

Pediatric manual instrumentation

EXPERIMENTAL

Primary mandibular molars treated with a manual pulpectomy and a Kedo-SH system.

Procedure: Manual pulpectomy

Adult rotatory instrumentation

ACTIVE COMPARATOR

Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system.

Procedure: Rotatory technique pulpectomy

Pediatric rotatory instrumentation

EXPERIMENTAL

Primary mandibular molars treated with a rotatory technique pulpectomy and a Kedo-S system

Procedure: Rotatory technique pulpectomy

Interventions

Rotatory technique pulpectomy PROCEDURE

Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system or a Kedo-S system.

Adult rotatory instrumentation; Pediatric rotatory instrumentation

Manual pulpectomy PROCEDURE

Primary mandibular molars treated with a manual pulpectomy and a K-file system or a Kedo-SH system.

Adult manual instrumentation; Pediatric manual instrumentation

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 4 to 8 years old.
• Both genders.
• Patients with an indication for pulpectomy for mandibular molars, based on the of Kuo and colleagues criteria (2006).
• Patients requiring pulpectomy in posterior teeth.
• Adequate dental structure of the crown.
• Patients with a remnant structure of at least two-thirds of the root.
• Patients with a medical file at the Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle.
• Patients with signed informed consent.

You may not qualify if:

• Patients requiring pulpotomy, extraction, or pulp regeneration therapy.
• Patients who are older than 9 years.
• An unrestorable tooth.
• Internal resorption in the roots visible on radiographs.
• Teeth with mechanical or carious perforations of the floor of the pulp chamber.
• Excessive pathologic root resorption involving more than a third of the root.
• Excessive pathologic loss of bone support, with loss of the normal periodontal attachment.
• Presence of a dentigerous or follicular cyst.
• Periapical or interradicular lesion involving the crypt of the developing permanent successor.
• Patients with the diagnosis of molar incisor hypomineralization (MIH).
• Patient's whose legal guardian does not provide their informed consent to participate in this study.
• Uncooperative patients.
• Elimination criteria
• a. Patients who do not complete the treatment or radiographic follow-up at least at a cut-off point.

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• Universidad Latinoamericana: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Clínica de Odontopediatría

Mexico City, 03100, Mexico

RECRUITING

Related Publications (21)

• Aiem E, Joseph C, Garcia A, Smail-Faugeron V, Muller-Bolla M. Caries removal strategies for deep carious lesions in primary teeth: Systematic review. Int J Paediatr Dent. 2020 Jul;30(4):392-404. doi: 10.1111/ipd.12616. Epub 2020 Feb 18.

  PMID: 31943437 RESULT

• Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.

  PMID: 15897335 RESULT

• Casas MJ, Kenny DJ, Johnston DH, Judd PL. Long-term outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. Pediatr Dent. 2004 Jan-Feb;26(1):44-8.

  PMID: 15080357 RESULT

• Crespo S, Cortes O, Garcia C, Perez L. Comparison between rotary and manual instrumentation in primary teeth. J Clin Pediatr Dent. 2008 Summer;32(4):295-8. doi: 10.17796/jcpd.32.4.l57l36355u606576.

  PMID: 18767460 RESULT

• Frencken JE, Sharma P, Stenhouse L, Green D, Laverty D, Dietrich T. Global epidemiology of dental caries and severe periodontitis - a comprehensive review. J Clin Periodontol. 2017 Mar;44 Suppl 18:S94-S105. doi: 10.1111/jcpe.12677.

  PMID: 28266116 RESULT

• Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.

  PMID: 10925773 RESULT

• Fuks, A.B., Guelmann, M., Kupietzky, A. (2012). Current developments in pulp therapy for primary teeth. Endodontic Topics, 23, 50-72. https://doi.org/10.1111/etp.12003

  RESULT

• Hecksher F, Vidigal B, Coelho P, Otoni D, Alvarenga C, Nunes E. Endodontic Treatment in Artificial Deciduous Teeth through Manual and Mechanical Instrumentation: A Pilot Study. Int J Clin Pediatr Dent. 2019 Jan-Feb;12(1):15-17. doi: 10.5005/jp-journals-10005-1581.

  PMID: 31496565 RESULT

• Kaur, R., Singh, R., Sethi, K., Garg, S., Miglani, S. (2014). Review article irrigating solutions in Pediatric Dentistry: literature review and update. J Adv Med Dent Sci, 2, 104- 115.

  RESULT

• Kher, M.S., Rao, A. Pulp therapy in primary teeth. Clin Dent Rev 4, 16 (2020). https://doi.org/10.1007/s41894-020-00081-z

  RESULT

• Lopes-Fatturi, Aluhê, Souza, Juliana Feltrin de, Menezes, José Vitor Nogara Borges, Fraiz, Fabian Calixto, & Assunção, Luciana Reichert da Silva. (2020). A Survival Analysis of Different Pulp Therapies in Decayed Primary Teeth. Pesquisa Brasileira em Odontopediatria e Clínica Integrada, 20, e4822. Epub April 27, 2020. https://dx.doi.org/10.1590/pboci.2020.038

  RESULT

• Manchanda S, Sardana D, Yiu CKY. A systematic review and meta-analysis of randomized clinical trials comparing rotary canal instrumentation techniques with manual instrumentation techniques in primary teeth. Int Endod J. 2020 Mar;53(3):333-353. doi: 10.1111/iej.13233. Epub 2019 Nov 26.

  PMID: 31587323 RESULT

• Muller-Bolla M, Garcia A, Aiem E, Domejean S. Dentists' decisions for deep carious lesions management in primary teeth. Int J Paediatr Dent. 2020 Sep;30(5):578-586. doi: 10.1111/ipd.12639. Epub 2020 Apr 7.

  PMID: 32189409 RESULT

• Ochoa-Romero T, Mendez-Gonzalez V, Flores-Reyes H, Pozos-Guillen AJ. Comparison between rotary and manual techniques on duration of instrumentation and obturation times in primary teeth. J Clin Pediatr Dent. 2011 Summer;35(4):359-63. doi: 10.17796/jcpd.35.4.8k013k21t39245n8.

  PMID: 22046692 RESULT

• Panchal V, Jeevanandan G, Erulappan SM. Comparison between the Effectiveness of Rotary and Manual Instrumentation in Primary Teeth: A Systematic Review. Int J Clin Pediatr Dent. 2019 Jul-Aug;12(4):340-346. doi: 10.5005/jp-journals-10005-1637.

  PMID: 31866721 RESULT

• Petersen PE, Bourgeois D, Ogawa H, Estupinan-Day S, Ndiaye C. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005 Sep;83(9):661-9. Epub 2005 Sep 30.

  PMID: 16211157 RESULT

• Pozos-Guillen A, Garcia-Flores A, Esparza-Villalpando V, Garrocho-Rangel A. Intracanal irrigants for pulpectomy in primary teeth: a systematic review and meta-analysis. Int J Paediatr Dent. 2016 Nov;26(6):412-425. doi: 10.1111/ipd.12228. Epub 2016 Feb 22.

  PMID: 26898157 RESULT

• Rawson TH, Rayes S, Strizich G, Salazar CR. Longitudinal Study Comparing Pulpectomy and Pulpotomy Treatments for Primary Molars of Alaska Native Children. Pediatr Dent. 2019 May 15;41(3):214-220.

  PMID: 31171074 RESULT

• Taylor GD, Vernazza CR, Abdulmohsen B. Success of endodontic management of compromised first permanent molars in children: A systematic review. Int J Paediatr Dent. 2020 May;30(3):370-380. doi: 10.1111/ipd.12599. Epub 2019 Dec 13.

  PMID: 31778237 RESULT

• Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2017 Sep 15;39(6):325-333. No abstract available.

  PMID: 29179372 RESULT

• Young DA, Novy BB, Zeller GG, Hale R, Hart TC, Truelove EL; American Dental Association Council on Scientific Affairs; American Dental Association Council on Scientific Affairs. The American Dental Association Caries Classification System for clinical practice: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2015 Feb;146(2):79-86. doi: 10.1016/j.adaj.2014.11.018.

  PMID: 25637205 RESULT

MeSH Terms

Conditions

Dental Pulp Diseases; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Study Officials

• Benjamín Franco Sánchez, DDS

  Universidad Latinoamericana

  PRINCIPAL INVESTIGATOR

• Marianela Hernández-Baños, DDS

  Universidad Latinoamericana

  PRINCIPAL INVESTIGATOR

• Jaime D Mondragon, MD, MSc

  University Medical Center Groningen, Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianela Hernández-Baños, DDS

CONTACT

+525545600120; neladentist@gmail.com

Benjamín Franco Sánchez, DDS

CONTACT

+525526902586; cdfranco@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessor will be blinded as the interventions can not be blinded to the participant and care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical researcher

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 19, 2020
• Study Start: December 8, 2020
• Primary Completion: December 15, 2021
• Study Completion: July 15, 2022
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the conclusion of the study.
• Access Criteria: Access granted by the principal investigators.

Locations

ME (1)