Clinical trial NCT04390854: Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth
Official title: Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulp Necroses
Keywords: Regenerative endodontics
Open apex
Immature necrotic teeth
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.

Detailed description: 30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.

Eligibility criteria: Inclusion Criteria:

* Necrotic incisors with immature roots
* Pulp space not needed for post and core.
* The patient has to be free from any coagulation disorders, with normal platelets count.
* Good oral hygiene
* Cooperative patient

Exclusion Criteria:

* Internal or external root resorption.
* Root fracture and/or alveolar fracture.
* Previous root canal treatment.
* Medically compromised patients
* Uncooperative patient

Primary outcomes:
measure: Subjective pain assessment
timeFrame: 1 month
measure: Subjective pain assessment
timeFrame: 3 months
measure: Subjective pain assessment
timeFrame: 6 months
measure: Subjective pain assessment
timeFrame: 12 months
measure: Assessment of pulp vitality
timeFrame: 1 month
measure: Assessment of pulp vitality
timeFrame: 3 months
measure: Assessment of pulp vitality
timeFrame: 6 months
measure: Assessment of pulp vitality
timeFrame: 12 months
measure: Assessment of root development
timeFrame: 1 month
measure: Assessment of root development
timeFrame: 3 months
measure: Assessment of root development
timeFrame: 6 months
measure: Assessment of root development
timeFrame: 12 months
measure: Assessment of the size of periapical radiolucency
timeFrame: 1 month
measure: Assessment of the size of periapical radiolucency
timeFrame: 1 month
measure: Assessment of the size of periapical radiolucency
timeFrame: 3 months
measure: Assessment of the size of periapical radiolucency
timeFrame: 3 months
measure: Assessment of the size of periapical radiolucency
timeFrame: 6 months
measure: Assessment of the size of periapical radiolucency
timeFrame: 6 months
measure: Assessment of the size of periapical radiolucency
timeFrame: 12 months
measure: Assessment of the size of periapical radiolucency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mahmoud MS Hassan, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mohamed Ibrahim, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Sybel M Moussa, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nihal A Lehita, PhD
role: STUDY_CHAIR
References:
citation: Bakhtiar H, Vatanpour M, Rayani A, Navi F, Asna-Ashari E, Ahmadi A, Jafarzadeh H. The plasma-rich in growth factor as a suitable matrix in regenerative endodontics: a case series. N Y State Dent J. 2014 Jun-Jul;80(4):49-53.
citation: Keswani D, Pandey RK. Revascularization of an immature tooth with a necrotic pulp using platelet-rich fibrin: a case report. Int Endod J. 2013 Nov;46(11):1096-104. doi: 10.1111/iej.12107. Epub 2013 Apr 13.
citation: Yassen GH, Eckert GJ, Platt JA. Effect of intracanal medicaments used in endodontic regeneration procedures on microhardness and chemical structure of dentin. Restor Dent Endod. 2015 May;40(2):104-12. doi: 10.5395/rde.2015.40.2.104. Epub 2014 Dec 24.
citation: Yassen GH, Sabrah AH, Eckert GJ, Platt JA. Effect of different endodontic regeneration protocols on wettability, roughness, and chemical composition of surface dentin. J Endod. 2015 Jun;41(6):956-60. doi: 10.1016/j.joen.2015.02.023. Epub 2015 Mar 29.
citation: Neha K, Kansal R, Garg P, Joshi R, Garg D, Grover HS. Management of immature teeth by dentin-pulp regeneration: a recent approach. Med Oral Patol Oral Cir Bucal. 2011 Nov 1;16(7):e997-1004. doi: 10.4317/medoral.17187.
citation: Lovelace TW, Henry MA, Hargreaves KM, Diogenes A. Evaluation of the delivery of mesenchymal stem cells into the root canal space of necrotic immature teeth after clinical regenerative endodontic procedure. J Endod. 2011 Feb;37(2):133-8. doi: 10.1016/j.joen.2010.10.009.
citation: Cotti E, Mereu M, Lusso D. Regenerative treatment of an immature, traumatized tooth with apical periodontitis: report of a case. J Endod. 2008 May;34(5):611-6. doi: 10.1016/j.joen.2008.02.029.
citation: Cehreli ZC, Isbitiren B, Sara S, Erbas G. Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series. J Endod. 2011 Sep;37(9):1327-30. doi: 10.1016/j.joen.2011.05.033. Epub 2011 Jul 13.
citation: Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019.