| CTRI Number |
CTRI/2019/09/021128 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
20/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Gum fill between the teeth. |
|
Scientific Title of Study
|
Comparison of connective tissue graft and platelet rich fibrin as matrices in a novel papillary augmentation access for patients with deficient interdental papilla using microsurgical approach – A randomised 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 |
DrS Sangeetha |
| Designation |
Reader |
| Affiliation |
SRM Dental College |
| Address |
Department of periodontics,
SRM Dental College,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
89
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrS Sangeetha |
| Designation |
Reader |
| Affiliation |
SRM Dental College |
| Address |
Department of periodontics,
SRM Dental College,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
89
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhura gadi |
| Designation |
Reader |
| Affiliation |
SRM Dental College |
| Address |
Department of periodontics,
SRM Dental College,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
89
India |
| Phone |
8939601846 |
| Fax |
|
| Email |
gadisindhura@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrSSangeetha |
| Address |
Department of periodontics,
SRM Dental College,
Ramapuram,
Chennai |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Sangeetha |
SRM Dental College |
Department of Periodontics.
Chennai
TAMIL NADU |
9884563217
sangeetha_doc@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW SRM DENTAL COLLEGE. BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deficient Interdental papilla |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Connective Tissue Graft and Platelet Rich Fibrin. |
To compare the papillary gain and reduction in black triangle height obtained at 6 months postoperatively between the Connective Tissue Graft(control) group and Platelet Rich Fibrin(test) group.
Clinical parameters to be evaluated: Full mouth as well as Site specific probing pocket depth, Site specific clinical attachment level, full mouth plaque scores, full mouth bleeding scores, height of the black triangle, papillary height,standardized photographs for visual analogue scale are to be taken at baseline and six months post surgically.
|
| Intervention |
Interdental papilla reconstruction using microsurgical approach. |
Using Microsurgical approach,Under L.A, a full thickness horizontal incision is given buccally at the level of MGJ. Crevicular incision given around the facial and palatal surface of the tooth. Tunnelling to be done from the incision on buccal aspect which is to connect with the tunneling on the palatal aspect. Insertion of the corresponding matrices done from buccal incision and passed over the crest of the bone.Horizontal mattress suture is placed on buccal side and graft is stabilised. A vertical mattress suture was placed on the interdental papilla and is suspended on the composite resin placed at the incisal edge of the teeth. The surgical site was covered with periodontal dressing.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Class I, II and I-II interdental papillary loss based on nordland and tarnow’s classification.
2. Recession less than 2mm on the facial aspect.
3. No active periodontal disease
4. Patients with adequate width of attached gingiva
5.No systemic conditions or medication known to interfere with periodontal tissue health or healing.
|
|
| ExclusionCriteria |
| Details |
1. Previous periodontal surgery within six months.
2. Pregnant / lactating women
3. Usage of tobacco / tobacco products in past 6 months.
4. Patients unwilling for the surgery.
5. Patients with inadequate plaque control.
6. Edentulous site adjacent to the site of surgery.
7. Platelet count less than one lakh cells per cubic mm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Papillary height
It is to be measured from base of the papilla to tip of the papilla using UNC probe.
2. Height of the black triangle
It is measured from the tip of the interdental papilla to the apical extent of the contact point using UNC probe.
|
At 6th month from baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale is an additional parameter measured as secondary outcome to be analysed at 6 months comparing baseline and 6th month photographs.
Visual analogue scale for papillary fill by a dental professional.
Visual analogue scale for esthetics by the patient.
|
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
23/09/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL.
manuscript is being prepared. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The current study proposes, minimal access labial and palatal crevicular incisions, so as to create a tunnel across the interdental gingiva, to facilitate placement of the Connective Tissue Graft in control group and Platelet Rich Fibrin in the test group so as to augment the papilla height under microsurgical approach. The required sample size is a total of 26 patients with 13 patients in each of the two groups.The clinical parameters that were evaluated are PH and BTH which were the primary outcome measures. VASD and VASP were secondary outcome measures along with site specific PPD, CAL, FMPS, FMBS. All the parameters are evaluated and compared at baseline and 6 months. VASD and VASP were evaluated and compared at 6months |