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.

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Key information

Conditions

Periapical Diseases Bone Cysts Cysts Jaw Cysts Jaw Diseases Mouth Diseases Musculoskeletal Diseases Neoplasms Odontogenic Cysts Periapical Cyst Periodontal Cyst Periodontal Diseases Radicular Cyst Stomatognathic Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams univetsity

Cairo, 11566, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apical microsurgery

Procedure

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: apicoectomy

Primary outcomes

Healing

Time frame: 12 months

Assessing healing using CBCT

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Jul 13, 2023
Registry last updated: Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed