An interventional study of Apical microsurgery in Periapical Diseases and Periapical Cyst, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
The goal of this triple blinded randomized clinical trial is to evaluate the effect of combining different bioactive root end filling materials with composite bone graft (xenogeneic mixed with autogenous bone fragments) on the healing process of periapical tissues after endodontic micro-surgery procedure on patients with small to moderate sized lesions. The main questions it aims to answer are:
Will the use of Totalfill in Endodontic surgeries show comparable results to the gold standard MTA? Will the addition of composite bone graft (Xenogenic and Autogenous) affect the healing of small to moderate sized lesions? Is there any interaction between composite bone graft and different bioactive root-end filling materials? Participants were allocated to 4 different groups according to the root-end filling material used with or without bone graft.
Reseachers compared between MTA only group, Totalfill only group, MTA with bone group, and Totalfill with bone group to evaluate healing of the periapical lesion using CBCT after 12 months follow up period.
44 studies on the registry are indexed under Periapical Diseases; 12 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 35 interventional studies indexed under Periapical Diseases.
Browse Periapical Diseases studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients must be medically free from any systemic disease that can affect bone healing.
Age range of the patient should be between 20 - 45 years old. All patients must have good oral hygiene. The size of the radiolucent area is of small-moderate size (up to 3 cm in highest diameter at any axis in CBCT), related to a single rooted maxillary tooth.
Periradicular disease in a root-filled tooth where orthograde root canal treatment options has failed,
Exclusion Criteria:
Patient with systemic disease that may affect bone healing. Patients above 45 years or patients below 20 years. Patients with very poor oral hygiene. Teeth presenting with apico-marginal defects or teeth with periodontal disease (periodontal pockets and/or mobility).
Surgery after previous endodontic surgery (re-surgery cases), root resections and amputations, cases presenting with root fractures.
Patients with history of allergies to any of the medications to be used during or after the surgery.
Root end filling material is MTA without bone graft in the defect.
Procedure: Apical microsurgery
Root end filling material is TotalFill without bone graft in the defect.
Procedure: Apical microsurgery
Root end filling material is MTA with the addition of composite bone graft in the defect.
Procedure: Apical microsurgery
Root end filling material is TotalFill with the addition of composite bone graft in the defect.
Procedure: Apical microsurgery
inoculation of the periapical or the periradicular lesion with the sectioning of the apical 3mm of the root followed by root-end cavity preparation and retro-filling with the MTA or TotalFill with or without composite bone grafting according to patient allocation.
Also known as: apicoectomy
Healing
Assessing healing using CBCT
Time frame: 12 months
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radicular Cyst
Ain Shams University