Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry

NCT04533074 | Terminated Phase 2

• 1 other identifier: MALDI-TOF MS regeneration
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols.

Conditions

Pulp Necroses; Tooth, Nonvital

Outcome Measures

Primary Outcomes (6)

• Microbiological assessment

  The presence or absence of reduction in types of micro-organisms in root canals

  24 hours

• Tooth vitality

  Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no).

  up to 12 months

• Tooth mobility

  4\. Mobility will be recorded according to Grace \& Smales Mobility Index * Grade 0: No apparent mobility * Grade 1: Perceptible mobility \<1mm in buccolingual direction * Grade 2: 1mm\< but \<2mm * Grade 3: 2mm\< or depressibility in the socket

  up to 12 months

• Healing of periapical lesions

  Periapical index score (PAI) will be used for identification of apical periodontitis on both periapical radiography and Cone-beam computed tomographic (CBCT). It is a 6-point (0 -5) scoring system with 2 additional variables, expansion of cortical bone and destruction of cortical bone.The PAI will be determined by the largest extension of the lesion on periapical radiography and CBCT scans in 3 dimensions: axial, sagittal, and coronal. * Score 0 Intact periapical bone structures. * Score 1 Diameter of periapical radiolucency "0.5-1 mm. * Score 2 Diameter of periapical radiolucency "1-2 mm. * Score 3 Diameter of periapical radiolucency "2-4 mm. * Score 4 Diameter of periapical radiolucency "4-8 mm. * Score 5 Diameter of periapical radiolucency "8 mm. * Score (n)# E: Expansion of periapical cortical bone. * Score (n)# D: Destruction of periapical cortical bone.

  up to 12 months

• Root lengthening

  The root length will be measured as a straight line from the CEJ to the radiographic apex of the tooth. This will be measured on both periapical radiography and Cone-beam computed tomographic (CBCT) in millimeters.

  up to 12 months

• Root thickening

  The dentinal wall thickness for both the preoperative and recall images will be measured at the level of the apical one third of the preoperative root canal length measured from the CEJ. The root canal width and the pulp space will be measured at this level, and the remaining dentin thickness will be calculated by subtracting the pulp space from the root canal width.

  up to 12 months

Study Arms (2)

Single-visit regeneration protocol

EXPERIMENTAL

Biological: Single-visit regeneration protocol

Multiple-visits regeneration protocol

ACTIVE COMPARATOR

Biological: Multiple-visits regeneration protocol

Interventions

Single-visit regeneration protocol BIOLOGICAL

In a single visit, access opening, minimal instrumentation and irrigation will be done. After irrigation and drying, the apical tissue will be irritated to evoke bleeding in the canal, using a precurved K-file 2mm past the apical foramen, with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. The bleeding will be stopped at a level that allows for 3-4 mm of restorative material. Three millimeters of Biodentine will then be placed directly over the blood clot of each tooth. A 3-4 mm layer of glass ionomer is flowed gently over the capping material. Each access cavity will be restored using composite resin.

Single-visit regeneration protocol

Multiple-visits regeneration protocol BIOLOGICAL

In the first visit, access opening, minimal instrumentation and irrigation will be done. The root canal will be then dried and filled with calcium hydroxide paste. The tooth will be sealed with an intermediate restorative material (IRM), and the patient will be dismissed for 1-4weeks. In the second appointment, response to initial treatment will be assessed and the steps will be repeated if symptoms are persistent. If there are no symptoms, evoking bleeding to the level of the cemento-enamel junction will be done followed by Biodentine application over the blood clot with final glass ionomer and composite restorations.

Multiple-visits regeneration protocol

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Immature permanent upper anterior teeth.
• Necrotic teeth confirmed by sensibility test.
• Teeth with periapical lesions confirmed by periapical radiograph using paralleling device.

You may not qualify if:

• Teeth with orthodontic wires or brackets.
• Patient with history of allergy to any medication.
• Patient with history of bleeding disorders.
• Patient with medical illness or taking medications.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (18)

• Garcia-Godoy F, Murray PE. Recommendations for using regenerative endodontic procedures in permanent immature traumatized teeth. Dent Traumatol. 2012 Feb;28(1):33-41. doi: 10.1111/j.1600-9657.2011.01044.x. Epub 2011 Jul 27.

  PMID: 21794081 BACKGROUND

• El Ashiry EA, Farsi NM, Abuzeid ST, El Ashiry MM, Bahammam HA. Dental Pulp Revascularization of Necrotic Permanent Teeth with Immature Apices. J Clin Pediatr Dent. 2016;40(5):361-6. doi: 10.17796/1053-4628-40.5.361.

  PMID: 27617376 BACKGROUND

• Diogenes A, Ruparel NB, Shiloah Y, Hargreaves KM. Regenerative endodontics: A way forward. J Am Dent Assoc. 2016 May;147(5):372-80. doi: 10.1016/j.adaj.2016.01.009. Epub 2016 Mar 24.

  PMID: 27017182 BACKGROUND

• Flanagan TA. What can cause the pulps of immature, permanent teeth with open apices to become necrotic and what treatment options are available for these teeth. Aust Endod J. 2014 Dec;40(3):95-100. doi: 10.1111/aej.12087.

  PMID: 25470507 BACKGROUND

• Aggarwal V, Miglani S, Singla M. Conventional apexification and revascularization induced maturogenesis of two non-vital, immature teeth in same patient: 24 months follow up of a case. J Conserv Dent. 2012 Jan;15(1):68-72. doi: 10.4103/0972-0707.92610.

  PMID: 22368339 BACKGROUND

• Altaii M, Richards L, Rossi-Fedele G. Histological assessment of regenerative endodontic treatment in animal studies with different scaffolds: A systematic review. Dent Traumatol. 2017 Aug;33(4):235-244. doi: 10.1111/edt.12338. Epub 2017 Apr 20.

  PMID: 28342218 BACKGROUND

• Saoud TMA, Ricucci D, Lin LM, Gaengler P. Regeneration and Repair in Endodontics-A Special Issue of the Regenerative Endodontics-A New Era in Clinical Endodontics. Dent J (Basel). 2016 Feb 27;4(1):3. doi: 10.3390/dj4010003.

  PMID: 29563445 BACKGROUND

• McTigue DJ, Subramanian K, Kumar A. Case series: management of immature permanent teeth with pulpal necrosis: a case series. Pediatr Dent. 2013 Jan-Feb;35(1):55-60.

  PMID: 23635900 BACKGROUND

• Khoshkhounejad M, Shokouhinejad N, Pirmoazen S. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes. J Dent (Tehran). 2015 Jun;12(6):460-8.

  PMID: 26884781 BACKGROUND

• Chaniotis A. The use of a single-step regenerative approach for the treatment of a replanted mandibular central incisor with severe resorption. Int Endod J. 2016 Aug;49(8):802-12. doi: 10.1111/iej.12515. Epub 2015 Aug 21.

  PMID: 26197881 BACKGROUND

• Nagata JY, Rocha-Lima TF, Gomes BP, Ferraz CC, Zaia AA, Souza-Filho FJ, De Jesus-Soares A. Pulp revascularization for immature replanted teeth: a case report. Aust Dent J. 2015 Sep;60(3):416-20. doi: 10.1111/adj.12342. Epub 2015 Jul 29.

  PMID: 26219350 BACKGROUND

• Saoud TM, Huang GT, Gibbs JL, Sigurdsson A, Lin LM. Management of Teeth with Persistent Apical Periodontitis after Root Canal Treatment Using Regenerative Endodontic Therapy. J Endod. 2015 Oct;41(10):1743-8. doi: 10.1016/j.joen.2015.07.004. Epub 2015 Aug 14.

  PMID: 26279479 BACKGROUND

• Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16.

  PMID: 18571000 BACKGROUND

• Chueh LH, Ho YC, Kuo TC, Lai WH, Chen YH, Chiang CP. Regenerative endodontic treatment for necrotic immature permanent teeth. J Endod. 2009 Feb;35(2):160-4. doi: 10.1016/j.joen.2008.10.019. Epub 2008 Dec 12.

  PMID: 19166764 BACKGROUND

• Tagelsir A, Yassen GH, Gomez GF, Gregory RL. Effect of Antimicrobials Used in Regenerative Endodontic Procedures on 3-week-old Enterococcus faecalis Biofilm. J Endod. 2016 Feb;42(2):258-62. doi: 10.1016/j.joen.2015.09.023. Epub 2015 Nov 11.

  PMID: 26577870 BACKGROUND

• Topcuoglu G, Topcuoglu HS. Regenerative Endodontic Therapy in a Single Visit Using Platelet-rich Plasma and Biodentine in Necrotic and Asymptomatic Immature Molar Teeth: A Report of 3 Cases. J Endod. 2016 Sep;42(9):1344-6. doi: 10.1016/j.joen.2016.06.005. Epub 2016 Jul 15.

  PMID: 27427186 BACKGROUND

• McCabe P. Revascularization of an immature tooth with apical periodontitis using a single visit protocol: a case report. Int Endod J. 2015 May;48(5):484-97. doi: 10.1111/iej.12344. Epub 2014 Aug 27.

  PMID: 25066513 BACKGROUND

• Estrela C, Bueno MR, Azevedo BC, Azevedo JR, Pecora JD. A new periapical index based on cone beam computed tomography. J Endod. 2008 Nov;34(11):1325-1331. doi: 10.1016/j.joen.2008.08.013. Epub 2008 Sep 17.

  PMID: 18928840 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pervine H. Sharaf, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Raef A Sherif, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Ashraf M Zaazou, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Rania M ElBackly, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: August 31, 2020
• Study Start: August 23, 2018
• Primary Completion: March 10, 2021
• Study Completion: March 15, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

EG (1)