To compare efficacy of Titanium Screw and Gutta Percha Sticks for obturation of Mental Foramen after Mental Nerve Neurectomy
Design
Single Blinded Randomized Controlled Trial
Settings and conduct
Oral and Maxillofacial Surgery Department of AFID, Pakistan
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Unilateral Pain with Typical Signs of Trigeminal Neuralgia
Past Medical History of Carbamezapine intake
No Odontogenic Cause of Pain
No Organic Cause of Pain
Exclusion criteria:
Atypical Facial Pain/Pain of Unknown Cause
Bilateral Pain/Uncommon Distribution
Longer than Normal Neuralgic Pain
Pain of Odontogenic Origin
Pain having Organic Cause
Intervention groups
One Group Had Titanium Screws for obturation of Mental Foramen in 2nd Group Gutta Percha Sticks were used for Obturation of Mental Foramen
Main outcome variables
Operators Ease
Remission Of Pain
Displacement of Obutating Material
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059527N1
Registration date:2023-09-28, 1402/07/06
Registration timing:prospective
Last update:2023-09-28, 1402/07/06
Update count:0
Registration date
2023-09-28, 1402/07/06
Registrant information
Name
AMMAR Yasir
Name of organization / entity
Armed Forces Institute of Dentistry
Country
Pakistan
Phone
+92 346 7330822
Email address
seirraalphayankee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-01-07, 1402/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mental Nerve Neurectomy: A Comparison Of Titanium Screw Versus Gutta Percha Obturation of Mental Foramen
Public title
Mental Nerve Neurectomy: A Comparison Of Titanium Screw VS Gutta Percha Obturation of Mental Foramen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral Pain with Typical Signs of Trigeminal Neuralgia
Past Medical History of Carbamezapine intake
No Odontogenic Cause of Pain
No Organic Cause of Pain
Exclusion criteria:
Atypical Facial Pain/Pain of Unknown Cause
Bilateral Pain/ Uncommon Distribution of Pain
Longer than Normal Neuralgic Pain
Pain of Odontogenic Cause
Pain having Organic Origin
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Patients assigned serial numbers as they got treatment. Evens in Titanium Screen Group and Odds in Gutta Percha Stick Group
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were blinded as they were not informed about the treatment modality used for management of their ailment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of AFID
Street address
AFID CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
918/Trg Dated 2020
Health conditions studied
1
Description of health condition studied
Trigeminal Neuralgia
ICD-10 code
G50.0
ICD-10 code description
Trigeminal neuralgia
Primary outcomes
1
Description
More Operators Compliance, Decreased Post Neurectomy Pain and Decreased Incidence of Displacement of Obturation materail will be observed in Titanium Screw Group
Timepoint
3 months after Intervention
Method of measurement
Operators ease will be measured using questionnaire. Displacement will be observed on Orthopantomogram and Remission of Pain will be assessed by using VAS.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Titanium Screw Group, After obtaining Informed Consent regarding the procedure and needs of it ,Peripheral neurectomy followed by Mental Foramen obturation using Titanium Screw will be performed. Operator's Compliance will be assessed immediately after the procedure. Post Op Displacement and remission of pain will be assessed after three months
Category
Treatment - Surgery
2
Description
Intervention group: Gutta Percha Group, After obtaining Informed Consent regarding the procedure and needs of it ,Peripheral neurectomy followed by Mental Foramen obturation using Gutta Percha Sticks will be performed. Operator's Compliance will be assessed immediately after the procedure. Post Op Displacement and Remession of pain will be assessed after three months
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
AFID
Full name of responsible person
Syed Ammar Yasir
Street address
AFID, CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 346 7330822
Email
seirraalphayankee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AFID
Full name of responsible person
Syed Ammar Yasir
Street address
AFID, CMH rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 314 5254504
Email
seirraalphayankee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AFID
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
AFID
Full name of responsible person
Syed Ammar Yasir
Position
Resident In Oral and Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Email
seirraalphayankee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
AFID
Full name of responsible person
Syed Ammar Yasir
Position
Resident in Speciality
Latest degree
Medical doctor
Other areas of specialty/work
Oral and MAXILLOFACIAL surgery
Street address
AFID, CMH Rawalpindi
City
Rawalpind
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Email
seirraalphayankee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
AFID
Full name of responsible person
Syed Ammar Yasir
Position
Resident in specialty
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Email
seirraalphayankee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol, Statistical Analysis Plan, Informed Consent Clinical Study Reports will be shared
When the data will become available and for how long
After Publication Of Study
To whom data/document is available
Medical Related Individuals
Under which criteria data/document could be used
Data Can be Used by Medical related Personal for the patients with Trigeminal Neuralgia
From where data/document is obtainable
Phone
Whatsapp
What processes are involved for a request to access data/document