| CTRI Number |
CTRI/2020/01/022697 [Registered on: 10/01/2020] Trial Registered Prospectively |
| Last Modified On: |
02/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of subepithelial connective tissue graft and PRF in the management of Black Triangle . |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of Subepithelial Connective Tissue Graft Versus Platelet Rich Fibrin Membrane In Surgical Reconstruction Of Interdental Papillae Using Han And Takie Technique – A Randomized Controlled Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Sharma |
| Designation |
Postgraduate student |
| Affiliation |
ITS-CDSR Muradnagar |
| Address |
Room no.5 ,Department of periodontics, ITS-CDSR,Muradnagar, ghaziabad
Room No. 5,Department of periodontics, ITS-CDSR,Muradnagar, ghaziabad
Ghaziabad
UTTAR PRADESH
201005
India |
| Phone |
9711227265 |
| Fax |
|
| Email |
drpreetimds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhra Vaish |
| Designation |
Professor |
| Affiliation |
ITS CDSR |
| Address |
Room no. 5, Department of Periodontics and Implantology,ITS Dental college, Muradnagar,Uttarpradesh
Room no. 5, Department of Periodontics and Implantology,ITS Dental college, Muradnagar,Uttarpradesh
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9811160638 |
| Fax |
|
| Email |
shubhravaish@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhra Vaish |
| Designation |
Professor |
| Affiliation |
ITS CDSR |
| Address |
Room no. 5, Department of Periodontics and Implantology,ITS Dental college, Muradnagar,Uttarpradesh
Room no. 5, Department of Periodontics and Implantology,ITS Dental college, Muradnagar,Uttarpradesh
Ballia
UTTAR PRADESH
201206
India |
| Phone |
9811160638 |
| Fax |
|
| Email |
shubhravaish@its.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Preeti Sharma |
| Address |
Flat no. M7A, A4 plot, shalimar garden ext 2, sahibabad, ghaziabad |
| 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 |
| Preeti Sharma |
ITS CDSR |
Muradnagar, Ghaziabad, Uttarpradesh
Ghaziabad
UTTAR PRADESH |
9711227265
drpreetimds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
localised periodontitis with class I and class II interdental papillary recession |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation Of Efficacy Of PRF In The Reconstruction Of Interdental Papilla |
Evaluation Of PRF In The Reconstruction Of Interdental Papilla Using Han and Takie Technique |
| Comparator Agent |
Evaluation of subepithelial connective tissue graft in the reconstruction of interdental papilla |
Evaluation of subepithelial connective tissue graft in the reconstruction of interdental papilla using Han and Takie technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with age group of 18 to 50 years.
2.All subjects who were systemically healthy.
3.Clinical evidence of presence of class I and II interdental papillae defects.
4.Subjects with no active periodontal infection.
5.Subjects who were willing to comply with all that study related procedure and willing to sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with full restoration and crown etc.
2.Endodontically involved teeth.
3.Subjects who were smokers.
4.Subjects taking any medication known to influence the periodontium.
5.Subjects with any systemic illness.
6.Pregnant and lactating mothers.
7.Subjects sensitive and allergic to any medicines used in study.
8.Inability to provide informed consent to the dentist.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Papillae Presence Index (PPI)
2.The Papillary Height (in mm) (PH)
3.The distance from the contact point to the tip of papillae ( in mm) (CPTP)
4.Radio-graphically the distance from contact point to alveolar crest (in mm) (CP-BC)
|
baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Plaque index ( PI)
2.Gingival index (GI)
3.Pocket probing depth (in mm) (PPD)
4.Relative Attachment Level (in mm) (RAL)
|
baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
13/01/2020 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COMPARATIVE EVALUATION OF EFFICACY OF SUBEPITHELIAL CONNECTIVE TISSUE GRAFT VERSUS PLATELET RICH FIBRIN MEMBRANE IN SURGICAL RECONSTRUCTION OF INTERDENTAL PAPILLAE USING HAN AND TAKIE TECHNIQUE –A RANDOMIZED CONTROLLED CLINICAL TRIAL. standardized clinical parameters measured icludes · Plaque index ( PI) Gingival index (GI) Pocket probing depth (in mm) (PPD) Relative Attachment Level (in mm) (RAL) Papillae Presence Index (PPI) The Papillary Height (in mm) (PH)The distance from the contact point to the tip of papillae ( in mm) (CPTP) Radio-graphically the distance from contact point to alveolar crest (in mm) (CP-BC) Plaque index ( PI) Gingival index (GI)Pocket probing depth (in mm) (PPD) Relative Attachment Level (in mm) (RAL) Papillae Presence Index (PPI) The Papillary Height (in mm) (PH) The distance from the contact point to the tip of papillae ( in mm) (CPTP) Radio-graphically the distance from contact point to alveolar crest (in mm) (CP-BC) |