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

Pulp Necroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04533074
• Other study ID #: MALDI-TOF MS regeneration
• Status: Terminated
• Phase: Phase 2
• Start date: August 23, 2018
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2022
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 15, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necroses
• Tooth, Nonvital

Intervention

Biological:
• Single-visit regeneration protocol
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.
• Multiple-visits regeneration protocol
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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (18)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Estrela C, Bueno MR, Azevedo BC, Azevedo JR, Pécora 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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). pii: E3. doi: 10.3390/dj4010003. Review. — View 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. — View Citation

Topçuoglu G, Topçuoglu 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological assessment	The presence or absence of reduction in types of micro-organisms in root canals	24 hours
Primary	Tooth vitality	Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no).	up to 12 months
Primary	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
Primary	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
Primary	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
Primary	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