| CTRI Number |
CTRI/2024/05/067043 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study for comparing the efficiency of two techniques , using injectable platelet rich fibrin and connective tissue grafting in gum reconstruction |
|
Scientific Title of Study
|
Efficacy of injectable platelet rich fibrin in interdental papilla reconstruction as compared to connective tissue grafting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeswin Johnson |
| Designation |
Junior resident |
| Affiliation |
Government dental college , Kottayam |
| Address |
Department of periodontics
Room no. 802
Government dental college
Gandhinagar
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
8921745269 |
| Fax |
|
| Email |
jeswinjohnson09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Baiju R M |
| Designation |
Additional Professor |
| Affiliation |
Government dental college , Kottayam |
| Address |
Department of Periodontics
Room No.802
Government Dental College Gandhinagar
Kottayam Kerala
Kottayam
KERALA
686008
India |
| Phone |
9447279605 |
| Fax |
|
| Email |
baijurm2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeswin Johnson |
| Designation |
Junior resident |
| Affiliation |
Government dental college , Kottayam |
| Address |
Department of periodontics
Room no. 802
Government Dental College
Gandhinagar
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
8921745269 |
| Fax |
|
| Email |
jeswinjohnson09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics
Room No. 802
Government Dental College
Kottayam |
|
|
Primary Sponsor
|
| Name |
Dr Jeswin Johnson |
| Address |
Department of periodontics
Room no.802
Government Dental College
Kottayam |
| 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 Jeswin Johnson |
Government Dental College Kottayam |
Department of periodontics
Room no. 802
Government Dental College
Kottayam
Kottayam
KERALA |
8921745269
jeswinjohnson09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Institutional Ethics Committee (IEC)/Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Connective tissue grafting |
Interdental papilla reconstruction using connective tissue grafting. Minimally invasive approaches are those procedures that involve less trauma. Connective tissue graft (CTG), considered as gold standard . A crevicular incision will be placed along the buccal and palatal region of the adjacent teeth without splitting the interdental gingiva. Tunnels will be prepared on the buccal and palatal aspect extending from the horizontal incision to the interdental area using tunneling knives. After placement CTG a horizontal mattress suture will be placed on the buccal and palatal aspect to stabilize the graft.
|
| Intervention |
Injectable Platelet Rich Fibrin |
Interdental papilla reconstruction using injectable platelet rich fibrin .Injectable platelet-rich fibrin (i-PRF) is the most recent and successful advancement in regenerative procedures. It has the ability and potential to release larger amounts of growth factors.At the site with loss of interdental papilla, adequate anesthesia will be obtained and the needle of insulin syringe will be inserted 2–3 mm apical to the papilla tip directed coronally making an angle of 45° to the long axis of the tooth with its bevel facing apically .Multiple injections will be done until the overlying mucosa appears blanched.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Otherwise systematically healthy individuals having at least one Nordland and Tarnows
Class I or Class II open gingival or cervical embrasure in maxillary anterior region
2. FMBS and FMPS less than 20 percentage
3. Selected teeth must be free of restorations on the cervical (buccal or proximal) region
4. Radiographically, the distance between contact point (CP) to alveolar crest should be less than or equal to 6 mm
5. Minimal probing depth (less than or equal to 2 mm) adjacent to the open embrasure |
|
| ExclusionCriteria |
| Details |
1. Smokers
2. Pregnant or lactating women
3. Previous periodontal surgery.
4. Undergoing active orthodontic treatment
5. Tooth mobility bruxism, missing or supernumerary teeth, mucogingival problem
(shallow vestibule, aberrant frenemy attachment, or inadequate zone of attached
gingiva)
6) Patients allergic to Ibuprofen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in interdental papilla height . |
baseline (0)
After 1 month
After 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in black triangle
height
Probing pocket depth (PPD) change
Clinical attachment level
(CAL) gain
|
baseline (0)
After 1 month
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/05/2024 |
| Date of Study Completion (India) |
25/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
SUMMARY
Interdental papillae, which is a component of the gingivae, are found in the space
between adjacent teeth. Open embrasures caused by interdental papillary loss can result in
various issues, including aesthetic problems, phonetic difficulties, and food impaction. Injectable platelet-rich fibrin is an autologous platelet concentrate possessing higher amounts
of growth factors that aid in regeneration. This study will assess whether black triangle width
is reduced or papilla fill will be enhanced by the use of i-PRF as good as CTG. Minimally invasive approaches include nonsurgical procedures and those procedures that
involve less trauma. The procedure involves :
•Allocation
of participants into test and control groups
•Connective
tissue grafting will be done on control group and injectable PRF is
injected into base of the papilla in test groups
•Measurements
of Black triangle height , Papillary Height will be taken and reviewed at first and third month
•Clinical
and photographic parameters will be re-recorded
•Data will be entered in MS Excel sheet
and will be transferred to SPSS for analysis.
This study is conducted to evaluate efficacy of i-PRF compared to autogenous connective tissue graft (CTG), considered as gold standard, in interdental papilla reconstruction. |