| CTRI Number |
CTRI/2024/02/062627 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of the lower jaw deviation after its partial removal |
|
Scientific Title of Study
|
Evaluation of mandibular deviation in post mandibulectomy patients- A cross-sectional 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 |
Dr Pankaj Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabah Cancer Hospital and Research Centre |
| Address |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Homi Bhabha Cancer Hospital and Research Centre Visakhapatnam
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
8178224559 |
| Fax |
|
| Email |
dr.prachichauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabah Cancer Hospital and Research Centre |
| Address |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Homi Bhabha Cancer Hospital and Research Centre Visakhapatnam
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
8178224559 |
| Fax |
|
| Email |
dr.prachichauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabah Cancer Hospital and Research Centre |
| Address |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Homi Bhabha Cancer Hospital and Research Centre Visakhapatnam
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
8178224559 |
| Fax |
|
| Email |
dr.prachichauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabah Cancer Hospital and Research Centre Visakhapatnam
|
|
|
Primary Sponsor
|
| Name |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Homi Bhabah Cancer Hospital and Research Centre Visahkapatnam
Agnampudi
Visakhapatnam
Andhra pradesh
530053 |
| Type of Sponsor |
Research institution 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 Pankaj Chauhan |
Homi Bhabah Cancer Hospital and Research Centre |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Visakhapatnam
ANDHRA PRADESH |
817824559
dr.prachichauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBCHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C03||Malignant neoplasm of gum, (3) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
18 to 70 year-old patient who has undergone resection of the mandible for Ca gingivobuccal complex (± upper alveolus) reconstructed with the soft tissue flap.
The post-surgery duration is at least 3 months or more.
Have a total of 6 or more teeth in both arches of the non-resected quadrant.
Have a mouth opening of at least 1.5 cm |
|
| ExclusionCriteria |
| Details |
Patients with major intra-oral defects such as total glossectomy or total maxillectomy limiting oral function.
Jaw reconstructed with bone or reconstruction plate
Non-consenting patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the mandibular deviation in segmental mandibulectomy patients and its correlation with chewing efficiency and QoL |
single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the mandibular deviation using dental midline, & mediolateral relation of maxillary & mandibular teeth.
Evaluation of extraoral deviation & its correlation with dental deviation & mediolateral relation of maxillary & mandibular teeth.
Analysis of deviation pattern with respect to time of surgical treatment, extent ofdefect, adjuvant treatment, use of guide bite prosthesis
Evaluate the functional outcome in terms of chewing efficiency using the mixing ability test & its correlation with the time of surgical treatment, the extent of defect, adjuvant treatment, use of guide bite prosthesis
Measure the QoL (quality of life) using EORTC QLQ-C30 & H&N35 & its correlation with the time of surgical treatment, the extent of defect, adjuvant treatment, & use of guide bite prosthesis. |
Baseline
As this study is a cross-sectional type of study all evaluations would be done at a single time for each participant whenever they would be reporting to the dental OPD. There will be only single-point data of all the participants & no follow-up data will be recorded & compared.
So we can say that baseline data will be collected as we have proposed a cross-sectional design of the study of mandibulectomy patients to study the amount of deviation.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Mandibulectomy is a surgical procedure that involves the removal of a portion of the mandible and this procedure is usually performed to treat oral cancer. Following a segmental mandibulectomy patients experience mandibular deviation towards the defect side if the continuity of the defect is not restored. Mandibular deviation can lead to functional in terms of mastication speech and swallowing and aesthetic as well as psychological issues thus adversely impacting the patient quality of life. Post-mandibulectomy rehabilitation involves a multidisciplinary approach which includes surgical reconstruction with bone or reconstruction plate the use of guide bite prosthesis and dental rehabilitation and physical therapy depending on the clinical situation and patients individual needs. No literature is present describing the amount of mandibular deviation in mandibulectomy patients. The aim of the proposed research is to analyze the mandibular deviation in segmental mandibulectomy patients and its effect on the masticatory efficiency and Quality of life in head and neck cancer patients. This is a Cross-sectional observational study that will enroll the mandibulectomy patients reporting to the dental OPD based on the inclusion and exclusion criteria. Outcome evaluation would quantify the degree of deviation in millimeters and assess the prevalence and severity of mandibular deviation. The deviations will be compared based on factors like the extent of the defect radiation treatment and prosthesis use. Chewing performance would be evaluated by the mixing ability. The chewing efficiency of study participants will be evaluated and compared between different subgroups based on the mentioned factors. The Quality of life would be evaluated by the EORTC QLQ-C30 and HN35. The outcome would assess the impact of mandibular deviation on the overall quality of life of participants and analyze differences in quality of life scores based on the time elapsed since surgery the extent of the defect radiation treatment and prosthesis use. The outcome would also analyze the effect of guide bite prosthesis usage on mandibular deviation chewing efficiency and quality of life by comparing outcomes between users at different time points. |