- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05943769
The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11566
- Ain Shams univetsity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MTA
Root end filling material is MTA without bone graft in the defect.
|
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.
Other Names:
|
Experimental: TotalFill
Root end filling material is TotalFill without bone graft in the defect.
|
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.
Other Names:
|
Experimental: MTA & bone
Root end filling material is MTA with the addition of composite bone graft in the defect.
|
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.
Other Names:
|
Experimental: TotalFill & bone
Root end filling material is TotalFill with the addition of composite bone graft in the defect.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing
Time Frame: 12 months
|
Assessing healing using CBCT
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDASU-RecID041910
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periapical Diseases
-
Seyda Ersahan, DDS, PhDActive, not recruitingApical Periodontitis | Periapical LesionTurkey
-
Cairo UniversityCompletedSymptomatic Periapical PeriodontitisEgypt
-
Cairo UniversityUnknownSymptomatic Periapical Periodontitis
-
University of the PacificCompletedPeriapical Abscess
-
Postgraduate Institute of Dental Sciences RohtakCompletedPeriapical LesionsIndia
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions
-
Cairo UniversityUnknownSymptomatic Periapical Periodontitis
-
Suez Canal UniversityNelly AbdElsalam; Dalia FayyadCompletedSymptomatic Periapical PeriodontitisEgypt
-
Dr. D. Y. Patil Dental College & HospitalUnknown
-
Cairo UniversityCompleted
Clinical Trials on Apical microsurgery
-
TC Erciyes UniversityUnknownInjury of Radial Artery at Wrist and Hand Level | Injury; Ulnar Artery, Hand and WristTurkey
-
University of ZurichMayo Clinic; Fondazione Policlinico Universitario Agostino Gemelli IRCCS; University... and other collaboratorsRecruitingAneurysm, BrainNetherlands, United States, Switzerland, Australia, Austria, Czechia, Germany, Italy, Russian Federation, Sweden
-
Universitaire Ziekenhuizen KU LeuvenRecruitingApical Periodontitis | Apical Periodontal CystBelgium
-
Jordan University of Science and TechnologyCompletedBone Resorption | SymptomsJordan
-
Cairo UniversityZagazig UniversityCompletedPostoperative PainEgypt
-
Istanbul Medipol University HospitalUnknownPostoperative Pain | Endodontically Treated Teeth
-
Centre hospitalier de l'Université de Montréal...University of AlbertaRecruitingIntracranial Aneurysm | Saccular Aneurysm | Unruptured Cerebral AneurysmCanada, France, Italy
-
Danish Head and Neck Cancer GroupActive, not recruitingHead and Neck Squamous Cell Carcinoma | Glottic T1Denmark
-
First Affiliated Hospital, Sun Yat-Sen UniversityUnknownVaricocele; Male Infertile;VaricocelectomyChina
-
Rio de Janeiro State UniversityCompleted