| CTRI Number |
CTRI/2024/03/063451 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of platelet concentrate obtained from patient own blood and amniotic layer which is is the inner layer of the unborn baby in the treatment of gums that pulls away from the teeth exposing the roots underneath |
|
Scientific Title of Study
|
Comparative evaluation of Platelet Rich Fibrin and Dehydrated Amniotic Membrane for the treatment of gingival recession by VISTA- a clinical 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 Prachi Jain |
| Designation |
PG student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Government Dental College and Hospital Main Road Rameshwar
Nagar Government Dental College and Hospital Main Road
Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9265704053 |
| Fax |
|
| Email |
jprachi0497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG Guide |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
101 Gulab Avenue Near Park Colony Jamnagar 361008 Government
Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Jain |
| Designation |
PG student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Government Dental College and Hospital Main Road Rameshwar
Nagar Government Dental College and Hospital Main Road
Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9265704053 |
| Fax |
|
| Email |
jprachi0497@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr Prachi Jain |
| Address |
Government Dental College and Hospital Main Road Rameshwar
Nagar Government Dental College and Hospital Main Road
Rameshwar Nagar
Jamnagar |
| Type of Sponsor |
Other [SELF] |
|
|
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 Prachi Jain |
Government Dental College and Hospital, Jamnagar |
Department of
Periodontology, Room
No. 112, GDCHJ,
Navagam.
Jamnagar
GUJARAT |
9265704053
jprachi0497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MP Shah Medical College and Guru Govind Singh Government Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
amniotic membrane |
After phase I the patient will be recalled Clinical parameters will be recorded Patient consent for surgery and LA will be taken Local anesthesia will be injected Single incision on mucous membrane and periosteum with scalpel 8 to 10 mm long incision beginning from mobile mucosa and reaching apical end of keratinized gingiva Small subperiosteal elevator will be inserted through insertion and will be used to free subperiosteal tunnel flap amniotic membrane will be placed Sutures will be taken Patient will be given post operative instructions Patient will be recalled for follow up after 1 week 1st month and 3rd month After 1st and 3rd month clinical parameters that are Percentage Root Coverage Clinical Attachment Level Keratinized Gingival Width Gingival Index and Plaque Index will be recorded |
| Intervention |
Platelet rich fibrin membrane |
After phase I the patient will be recalled Clinical parameters will be recorded
Patient consent for surgery and LA will be taken
Local anesthesia will be injected Single incision on mucous membrane and periosteum with scalpel 8 to 10 mm long incision beginning from mobile mucosa and reaching apical end of keratinized gingiva Small subperiosteal elevator will be inserted through insertion and will be used to free subperiosteal tunnel flap
Platelet rich fibrin membrane will be placed Sutures will be taken Patient will be given post operative instructions
Patient will be recalled for follow up after 1 week 1st month and 3rd month After 1st and 3rd month clinical parameters that are Percentage Root Coverage Clinical Attachment Level Keratinized Gingival Width Gingival Index and Plaque Index will be recorded
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Miller’s class I and class II recession,
more than 1mm width of attached gingiva and
Minimum 2 and maximum 6 sites.
|
|
| ExclusionCriteria |
| Details |
Surgical intervention in past 6 months,
Systemic history and
Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage Root Coverage |
1st month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Attachment Level, Keratinized Gingival Width, Gingival Index and Plaque Index |
1st month and 3rd month |
|
|
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)
|
01/04/2024 |
| 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="6"
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
|
Patient
referred to the department of periodontia, will be screened for multiple
tooth recession. After fulfilling the inclusion and exclusion criteria patient
will be informed. After informing the patient about the study and completing the
formalities in the consent form, the patients will be enrolled and data
collection in the proforma will be done.After phase I the patient will be recalled. Clinical
parameters will be recorded. Patient consent for surgery and LA
will be taken. Local anesthesia will be injected. Single
incision on mucous membrane & periosteum with scalpel. 8
to 10 mm long incision beginning from mobile mucosa and
reaching apical end of keratinized gingiva. Small
subperiosteal elevator will be inserted through insertion & will be used to
free subperiosteal tunnel flap.
Platelet rich fibrin membrane/amniotic membrane will be placed.
Sutures will be taken. Patient
will be given post operative instructions. Patient will be recalled for follow
up after 1 week, 1st month and 3rd month. After
1st and 3rd month clinical parameters i.e.
Percentage Root Coverage, Clinical
Attachment Level, Keratinized Gingival Width, Gingival Index and Plaque Index will
be recorded. |