Back to results

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

Primary Purpose

Pulp Necroses, Tooth, Nonvital

Status

Terminated

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Single-visit regeneration protocol

Multiple-visits regeneration protocol

About this trial

This is an interventional treatment trial for Pulp Necroses

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single-visit regeneration protocol

Multiple-visits regeneration protocol

Arm Description

Outcomes

Primary Outcome Measures

Microbiological assessment

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

Tooth vitality

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

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

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04533074

First Posted

August 27, 2020

Last Updated

March 13, 2022

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04533074

Brief Title

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

Official Title

Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

due to the COVID-19 pandemic

Study Start Date

August 23, 2018 (Actual)

Primary Completion Date

March 10, 2021 (Actual)

Study Completion Date

March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

Thirty patients with necrotic immature permanent teeth showing periapical lesions will be randomly divided in two groups: group (1) single visit regeneration and group (2) multiple visits regeneration protocol, in which calcium hydroxide will be applied for one week or more according to resolution of signs and symptoms. Dentin debris collected on a file will be taken as microbiologic sample to be cultured and examined by MALDI-TOF MS. This will be performed after the access cavity preparation and after irrigation in both groups, these samples will be labelled A and B, respectively. In group (2) there will be a third sample labeled C which will be taken after the removal of the intra canal calcium hydroxide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulp Necroses, Tooth, Nonvital

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-visit regeneration protocol

Arm Type

Experimental

Arm Title

Multiple-visits regeneration protocol

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Single-visit regeneration protocol

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Multiple-visits regeneration protocol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Microbiological assessment

Description

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

Time Frame

24 hours

Title

Tooth vitality

Description

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

Time Frame

up to 12 months

Title

Tooth mobility

Description

Time Frame

up to 12 months

Title

Healing of periapical lesions

Description

Time Frame

up to 12 months

Title

Root lengthening

Description

Time Frame

up to 12 months

Title

Root thickening

Description

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Immature permanent upper anterior teeth. Necrotic teeth confirmed by sensibility test. Teeth with periapical lesions confirmed by periapical radiograph using paralleling device. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pervine H. Sharaf, M.Sc

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raef A Sherif, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ashraf M Zaazou, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rania M ElBackly, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21512

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

21794081

Citation

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.

Results Reference

background

PubMed Identifier

27617376

Citation

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.

Results Reference

background

PubMed Identifier

27017182

Citation

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.

Results Reference

background

PubMed Identifier

25470507

Citation

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.

Results Reference

background

PubMed Identifier

22368339

Citation

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.

Results Reference

background

PubMed Identifier

28342218

Citation

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.

Results Reference

background

PubMed Identifier

29563445

Citation

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.

Results Reference

background

PubMed Identifier

23635900

Citation

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.

Results Reference

background

PubMed Identifier

26884781

Citation

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.

Results Reference

background

PubMed Identifier

26197881

Citation

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.

Results Reference

background

PubMed Identifier

26219350

Citation

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.

Results Reference

background

PubMed Identifier

26279479

Citation

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.

Results Reference

background

PubMed Identifier

18571000

Citation

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.

Results Reference

background

PubMed Identifier

19166764

Citation

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.

Results Reference

background

PubMed Identifier

26577870

Citation

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.

Results Reference

background

PubMed Identifier

27427186

Citation

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.

Results Reference

background

PubMed Identifier

25066513

Citation

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.

Results Reference

background

PubMed Identifier

18928840

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs