CTRI Number |
CTRI/2023/11/060236 [Registered on: 24/11/2023] Trial Registered Prospectively |
Last Modified On: |
14/06/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study to compare effects of two different surgery techniques on speech in children with tongue tie |
Scientific Title of Study
|
Comparative Evaluation of Speech Articulation Outcomes using
Frenectomy with Linear Closure versus Z Plasty for Management of
Ankyloglossia in Paediatric Subjects A Prospective Randomized
Control Study. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Varad Rajendra Saptarshi |
Designation |
Post Graduate Resident |
Affiliation |
MGM Dental College & Hospital Navi Mumbai |
Address |
MGM Dental College & Hospital Kamothe 4th Floor, Department of
Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 &
19), Kamothe, Navi Mumbai, 410209.
Raigarh MAHARASHTRA 410209 India |
Phone |
9860203496 |
Fax |
|
Email |
drvaradsaptarshi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Adil Gandevivala |
Designation |
Associate Professor |
Affiliation |
MGM Dental College & Hospital Navi Mumbai |
Address |
MGM Dental College & Hospital Kamothe 4th Floor, Department of
Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 &
19), Kamothe, Navi Mumbai, 410209.
Raigarh MAHARASHTRA 410209 India |
Phone |
9096815606 |
Fax |
|
Email |
dr.adilg@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Adil Gandevivala |
Designation |
Associate Professor |
Affiliation |
MGM Dental College & Hospital Navi Mumbai |
Address |
MGM Dental College & Hospital Kamothe 4th Floor, Department of
Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 &
19), Kamothe, Navi Mumbai, 410209.
Raigarh MAHARASHTRA 410209 India |
Phone |
9096815606 |
Fax |
|
Email |
dr.adilg@gmail.com |
|
Source of Monetary or Material Support
|
MGM Dental College and Hospital |
|
Primary Sponsor
|
Name |
MGM Dental College and Hospital |
Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and
19 Kamothe Navi Mumbai 410209 |
Type of Sponsor |
Other [Private Dental College and Hospital] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Varad Rajendra Saptarshi |
MGM DENTAL COLLEGE AND HOSPITAL |
MGM Dental College &
Hospital Kamothe 4th
Floor, Department of
Oral & Maxillofacial
Surgery, Plot No. 1 & 2,
Sector - 01(Old 18 &
19), Kamothe, Navi
Mumbai, 410209. Raigarh MAHARASHTRA |
9860203496
drvaradsaptarshi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee MGM Dental College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Q381||Ankyloglossia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Linear Closure |
Surgical release of Lingual frenum followed by closure with linear technique using resorbable suture |
Intervention |
Z plasty Closure |
Surgical release of Lingual frenum followed by closure with Z plasty technique using resorbable suture |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
11.00 Year(s) |
Gender |
Both |
Details |
Patients within the age group 03 to 11 years. |
|
ExclusionCriteria |
Details |
1. Any congenital abnormality in the craniofacial region.
2. Children with abnormal mental development.
3. Cleft abnormalities affecting speech.
4. Maxillofacial deformities affecting speech. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate and compare Speech Articulation Outcomes following Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects |
Preoperative speech evaluation.
Postoperative speech evaluation at 3 months. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate and compare Volume of the Upper Airway following
Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects. |
Preoperative radiographic evaluation.
Postoperative radiographic evaluation at 3 months. |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
02/12/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Ankyloglossia, commonly known as tongue-tie, is a congenital anomaly characterized by an abnormally short lingual frenulum. The phenotype varies from absence of clinical significance to rare complete ankyloglossia where the ventral part of the tongue is fused to the floor of the mouth. Ankyloglossia is anatomically characterized by an abnormally short, thick, or tight tongue frenulum and limits tongue movement, which may contribute to multiple dysfunctions, including difficulties in breastfeeding, swallowing, and speech articulation. Tongue-tie has been suggested to cause breast-feeding difficulties (sore nipples, poor infant weight gain, early weaning), speech disorders (impaired articulation), problems with deglutition and dentition, oral-motor dysfunction and social issues related to the limited function of the tongue. Tongue-tie can be considered a relatively common anomaly with a prevalence of approximately 4—5%. For unknown reasons the abnormality seems to be more common in males with male to female ratio of 2.3—2.7:1.0 Despite the fact that breastfeeding problems are thought to be the most common therapeutic indication among newborn infants with ankyloglossia, defects in articulation are the main complaints of preschoolers and older children. Recognition of the negative role of a short lingual frenulum led specialists to develop sophisticated protocols to investigate infants and children with short lingual frenuluae, but the association between a short lingual frenulum and OSAS is currently unrecognized. The most common method to correct ankyloglossia is by the surgical excision of aberrant frenal attachments. Although a lot of literature is available on the methods and techniques to correct ankyloglossia , scant literature is available in which postoperative speech has been assessed with the use of different techniques. Thus, the present study aims to evaluate and compare the speech outcomes with the use of 2 different techniques of closure. The study also aims to evaluate the improvement in the anatomy of the airway as a direct result of frenectomy , if any. |