| CTRI Number |
CTRI/2021/09/036557 [Registered on: 16/09/2021] Trial Registered Prospectively |
| Last Modified On: |
17/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
treatment of receeding gums using palatal graft: A 6 month follow up study |
|
Scientific Title of Study
|
Treatment of localised gingival recession with interdental attachment loss using gingival unit grafts: A 6 month follow up study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neelima Katti |
| Designation |
Assistant Professor |
| Affiliation |
SCB dental college and Hospital |
| Address |
Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India
Cuttack
ORISSA
753007
India |
| Phone |
13446 |
| Fax |
|
| Email |
kattineelima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelima Katti |
| Designation |
Assistant Professor |
| Affiliation |
SCB dental college and Hospital |
| Address |
Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India
ORISSA
753007
India |
| Phone |
13446 |
| Fax |
|
| Email |
kattineelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neelima Katti |
| Designation |
Assistant Professor |
| Affiliation |
SCB dental college and Hospital |
| Address |
Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India
ORISSA
753007
India |
| Phone |
13446 |
| Fax |
|
| Email |
kattineelima@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Neelima Katti |
| Address |
SCB dental college and Hospital ,
Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India |
| 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 |
| DrNeelima Katti |
SCB dental college and Hospital |
Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India
Cuttack
ORISSA |
9337613446
kattineelima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee SCB dental college and hospital, cuttack, odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with gingival recession in the anterior region of the oral cavity |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
gingival unit graft surgery |
25 patients with miller’s class III & RT2 recession , will be enrolled to receive gingival unit grafts. Plaque and gingival index will be scored at baseline after scaling, at 4 weeks and subsequently at every post surgical visit of the patient. Post surgery ,the patients will be recalled every two weeks for the first two months and once every month thereafter for 18months. Recession depth, recession width, probing depth, keratinised gingiva width, clinical attachment level both at donor and recipient site will be recorded at baseline 1 month, 3 months, 6 months period. Supra gingival polishing at each of these visits may be done as required. In addition a healing index for the donor site at 1 week, 2 weeks, 3 weeks, 4 weeks and an esthetic score for the recipient site at six months will be recorded. |
| Comparator Agent |
Not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
25 patients with miller’s class III & RT2 recession , will be enrolled to receive gingival unit grafts. Plaque and gingival index will be scored at baseline after scaling, at 4 weeks and subsequently at every post surgical visit of the patient. Post surgery ,the patients will be recalled every two weeks for the first two months and once every month thereafter for 18months. Recession depth, recession width, probing depth, keratinised gingiva width, clinical attachment level both at donor and recipient site will be recorded at baseline 1 month, 3 months, 6 months period. Supra gingival polishing at each of these visits may be done as required. In addition a healing index for the donor site at 1 week, 2 weeks, 3 weeks, 4 weeks and an esthetic score for the recipient site at six months will be recorded. |
|
| ExclusionCriteria |
| Details |
Inclusion criteria:
1.Isolated RT2 buccal recession defects with depth ≥3mm and clinically identifiable cement enamel junction (CEJ) in mandibular anterior
2. No active periodontal disease
Exclusion criteria:
1. Prominent or maloccluded teeth,which might require orthodontic correction prior to root coverage procedure.
2. Presence of non-cervical carious lesions or root caries.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in recession depth |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| root coverage esthetics score |
6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kattineelima@gmail.com].
- For how long will this data be available start date provided 01-09-2022 and end date provided 07-09-2021?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The primary aim of the study is to :Assess the efficetiveness of gingival unit graft in the treatment of gingival recession with interdental attachment loss |