| CTRI Number |
CTRI/2021/12/038682 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Treatment of gum recession using grafts prepared from blood |
|
Scientific Title of Study
|
Evaluation of clinical efficacy of advanced platelet rich fibrin and advanced platelet rich fibrin plus in the management of gingival recession defects-A prospective comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontics, 4th floor, SRM Dental College, Ramapuram campus, Bharathi salai,
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontics, 4th floor, SRM Dental College, Ramapuram campus, Bharathi salai,
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontics, 4th floor, SRM Dental College, Ramapuram campus, Bharathi salai,
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, SRM Dental College |
|
|
Primary Sponsor
|
| Name |
Dr Anupama Tadepalli |
| Address |
Department of Periodontics, 4th floor, SRM Dental College, Ramapuram campus, Bharathi salai,
Chennai |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Anupama Tadepalli |
SRM dental hospital |
Department of Periodontics, 4th floor, SRM Dental College, Ramapuram campus, Bharathi salai,
Chennai
Chennai
TAMIL NADU |
9677065517
anupamamds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with gingival recession defects in maxillary anteriors and premolars
2. Minimum recession ≥ 2mm
3. Systematically healthy patients
|
|
| ExclusionCriteria |
| Details |
1. Recession sites with probing depth ≥ 4mm and mobile teeth
2. Teeth with prosthetic restorations
3. Anemic patients
4. Platelet disorders
5. Smokers
7. Pregnant and lactating women
8. Patients with poor oral hygiene
9. Systemic condition /disease/any medication influencing the periodontal therapy and disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the changes in Recession height (RH) before and after therapy with in and between groups
|
Baseline, 3 months, 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare changes in
1.Gingival biotype
2.Width of attached gingiva |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2021 |
| Date of Study Completion (India) |
10/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gingival recession is the exposure of root surface due to displacement of gingival margin apical to the cementoenamel junction. Vigorous tooth brushing (most common causative factor) high frenal attachments, plaque, calculus and iatrogenic factors are responsible for the recession. The subepithelial connective tissue graft along with coronally advanced flap technique is the gold standard (Chambrone et al., 2008) (Cairo et al., 2014) and it is the most predictable technique for root coverage. Harvesting connective tissue has inherent limitations like second surgical site and donor site morbidity (pain, discomfort and difficulty during eating, swallowing). Additionally procuring sufficient connective tissue graft material for treating multiple gingival recessions is technically challenging. Recent modifications of the PRF preparation procedure (2700rpm for 12min 708G) have led to the development of advanced platelet rich fibrin 1500 rpm 14min 200G (A-PRF) and 1500 rpm 8min 200G(A-PRF+) which uses lower G forces proven to have greater number of platelets and growth factor content. Their application in recession management was not documented. This study proposes to investigate and compare clinical efficacy of A-PRF and A-PRF+ membranes in management of gingival recession defects along with coronally advanced flap.
|