Alexandria Faculty of Dentistry
Alexandria, Egypt
Location status: Recruiting
Location contact
Hamdy m Abou Almakarem, BDS
CONTACT
Hamdy m Abou Almakarem, msc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07357233
General aim: assessment of post operative pain and time of preparation with the execution of manual-less technique and conventional technique.
Specific aim: correlation between post operative pain and release of Substance P and Calcitonin gene-related peptide.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Alexandria, Egypt
Location status: Recruiting
Hamdy m Abou Almakarem, BDS
CONTACT
Hamdy m Abou Almakarem, msc
PRINCIPAL_INVESTIGATOR
Background: Post-operative pain (POP) remains a significant challenge after root canal treatment. A recent approach emphasizes objective pain assessment by measuring neuropeptides like substance P (SP) and calcitonin gene-related peptide (CGRP). Rotary nickel-titanium (NiTi) instruments have largely replaced manual stainless-steel files, improving efficiency, maintaining original root canal anatomy and reducing errors. Advances such as controlled memory (CM) files help minimize debris extrusion, potentially lowering POP. A fully rotary approach, eliminating the need for manual scouting and glide path creation, could offer a faster, more predictable alternative. This approach could be named as manual-less technique.
Aim: This study compares between manual-less instrumentation technique (excluding scouting and glide path step) versus conventional rotary instrumentation technique on the post operative pain and release of SP and CGRP.
Materials and methods: A total of 34 permanent molars with symptomatic irreversible pulpitis and apical periodontitis will be included in this study. They will be randomly divided into 2 groups (n=17): group I(manual-less): canal preparation using Dota rotary files escaping scouting and glide path step and Group II (conventional): canal preparation using Dota rotary files with prior scouting and glide path with hand files. Elisa analysis will be done for measuring level of SP and CGRP before and after instrumentation.
Analysis: All data will be collected and statistically analyzed with the appropriate statistical tests.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Canals preparation with rotary dota files escaping scouting and glide path step
Canal preparation with rotary drill files, with prior scouting and glide path with hand files.
Time frame: 6 hours,12 hours,24 hours,48 hours,72 hours
Numeric rating scale ranges from zero to 10. zero means no pain and 10 means severe pain.
Time frame: first sample in the first visit immediatly post instrumentation ,second sample in the second visit72hr
ELISA Kit will be used
Contact information is provided by the study sponsor or research team.
Sybel Moussa, PHD
CONTACT
hamdy Abou Almakarem, Msc
CONTACT
Alexandria University
Other
Impact Of Manual-Less Root Canal Instrumentation Versus Conventional Rotary Instrumentation On Post Operative Pain And Level Of Neuropeptides: Randomized Controlled Clinical Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT06349772
Neurologic Manifestations, Pain
Lubbock, Texas, United States
View Trial DetailsNCT07680998
Agnosia, Chronic Pain
Nîmes, Gard, France
View Trial DetailsNCT05110989
Neurologic Manifestations, Pain
Jacksonville, Florida, United States
View Trial DetailsNCT06123715
Chronic Pain, Knee Pain Chronic
Toronto, Ontario, Canada
View Trial Details