| CTRI Number |
CTRI/2024/09/073544 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
" A study designed to compare if the Root Plastique Technique is better to be done alone or in combination with I-PRF to cover the exposed root surface with Non Carious Cervical lesions " |
|
Scientific Title of Study
|
To compare the effectiveness of Root Plastique Technique with or without I-PRF on root coverage and gingival phenotype in subjects with Non Carious Cervical lesions
– A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muskan Gupta |
| Designation |
Post Graduate |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no 9, Department of Periodontology, JSS Dental college and hospital, Mysuru
Mysore KARNATAKA 570015 India |
| Phone |
8930877425 |
| Fax |
|
| Email |
Aashigarg1204@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Avinash BS |
| Designation |
Reader |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no 9, Department of Periodontology, JSS Dental college and hospital, Mysuru
Mysore KARNATAKA 570015 India |
| Phone |
|
| Fax |
|
| Email |
Dr.avinashbs@jssuni.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Muskan Gupta |
| Designation |
Post Graduate |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no 9, Department of Periodontology, JSS Dental college and hospital, Mysuru
Mysore KARNATAKA 570015 India |
| Phone |
8930877425 |
| Fax |
|
| Email |
Aashigarg1204@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital, Sri, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka
570015 |
|
|
Primary Sponsor
|
| Name |
Dr Muskan Gupta |
| Address |
Room No 9, Department of Periodontology, JSS Dental college and Hospital, Bannimantap, Mysuru, Karnataka
570015 |
| 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 Muskan Gupta |
JSS Dental college and Hospital/ JSS Academy Of Higher Education and Research |
Department Of Periodontology,Room no.9 Mysore KARNATAKA |
8930877425
Aashigarg1204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy, presenting with non carious cervical lesions with recession |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Root PLastique Technique alone |
The Apical step of the NCCL will be eliminated using rotary burs. The first cutter is rugby ball-shaped with a diameter of 0.16 white ring, ultra-fine grain with a maximum grain size of 14 microns. The bur will be inserted into the sulcus under abundant irrigation, until it invades the supra-crestal tissue attachment causing bleeding within the sulcus. Eliminating the apical step will be done to flatten the NCCL in the apical portion. The coronal projection of the most external point of the apical border of NCCL will be removed, reaching with the bur to the bottom of the NCCL. In this way, the depth of NCCL will be eliminated. Subsequently, a final preparation drill with a diameter of 012 white ring, ultra fine grain with a maximum grain size of 8 microns will be used. The bone crest will be reached using the bur gently while checking the working depth with the probe. An ultra fine finishing bur will be used to ensure minimal cutting on the expense of soft tissue and maximum smoothness of the root surface. |
| Intervention |
Root plastique technique with I-PRF |
Test group:-
The Apical step of the NCCL will be eliminated using rotary burs. The first cutter is rugby ball-shaped with a diameter of 0.16 white ring, ultra-fine grain with a maximum grain size of 14 microns. The bur will be inserted into the sulcus under abundant irrigation, until it invades the supra-crestal tissue attachment. Eliminating the apical step will be done to flatten the NCCL in the apical portion. The coronal projection of the most external point of the apical border of NCCL will be removed, reaching with the bur to the bottom of the NCCL. In this way, the depth of NCCL will be eliminated. Subsequently, a final preparation drill with a diameter of 012 white ring, ultra fine grain with a maximum grain size of 8 microns will be used. The bone crest will be reached using the bur gently while checking the working depth with the probe. An ultra fine finishing bur will be used to ensure minimal cutting on the expense of soft tissue and maximum smoothness of the root surface.
Preparation of I-PRF:-
Skin will be cleaned with alcohol swabs and blood will be drawn with blood collector needle of 21 gauge. Blood will be collected in a 10ml test tube and will be subjected to centrifugation. After which the tubes will be carefully taken out from the centrifuge and placed in a test tube stand. An insulin syringe will be used to extract the buffy coat and I-PRF will be the injected at the sides mesial, mid-buccal, and distal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
-Presence of gingival recession with NCCL and recession less then 2mm bilaterally .
- Only maxillary teeth will be included.
-Absence of caries and/or restorations in the area to be treated.
-Absence of mucogingival surgery or surgical treatment for periodontal disease at the same site in the previous 12 months.
-Full mouth plaque score (FMPS) less than 20 percent and full mouth bleeding score (FBS) less than 20 percent. |
|
| ExclusionCriteria |
| Details |
-Systemic diseases, pregnancy and lactation.
-Smoking, use of tobacco in any form and recreational drug users.
-If the defect and GR is more than 2mm and without the presence of a gingival step.
-Any evidence of trauma from occlusion in the area to be treated.
-Malocclusion, Crowding.
-Patients with poor oral hygiene. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of root plastique technique in recession coverage using clinical methods. |
Baseline, 2nd week, 6th week, 10th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare the effectiveness of injectable Platelet Rich Fibrin as an adjunct to root plastique technique in recession coverage using clinical methods.
-To assess changes in gingival phenotype |
Baseline, 2nd week, 6th week, 10th week, 12th week |
|
|
Target Sample Size
|
Total Sample Size="27" Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The term gingival phenotype has been introduced to address
the common clinical observation of great variation in the thickness and width
of facial keratinized tissue. Gingival biotype is described as the thickness of
the gingiva in the faciopalatal / faciolingual dimension. The term periodontal
biotype introduced by Seibert and Lindhe categorised the gingiva into
thick-flat and thin scalloped biotypes. Gingival thickness, keratinized tissue
width, and bone morphotype are three important parameters used to categorise
periodontal health. Thin gingival phenotype may contribute to periodontal
tissue breakdown and recession development. Gingival recession (GR) is defined
as the apical shift of the gingival margin with a consequent exposure of the
root surface. Various factors responsible for the etiopathogenesis of GR
include toothbrushrelated trauma, inflammation induced by plaque accumulation,
orthodontic tooth movement, and lack of keratinized tissue thickness (KTT). GRs
presents with wedge-shaped, concave, flattened, and irregular defects in the
cervical area of the teeth known as non-carious cervical lesions (NCCLs). The
presence of an NCCL leads to alterations in both crown and root surface that
often develop into root concavities (or steps) of variable extensions and
depths. There is relatively high frequency of non-carious cervical lesions
among subjects of different age. Premolars are the most frequently affected
teeth, therefore addressing this becomes very crucial for the clinician which
if left untreated may lead to periodontitis which induces the destruction of
tooth supporting tissues. There are various treatment modalities for recession
coverage one of it being Platelet-rich fibrin (PRF). PRF is developed by
centrifugation of blood obtained in glass tubes without anticoagulants and
activators. Injectable platelet-rich fibrin (i-PRF) is produced by changing the
type of the tube, centrifugation time and speed. I-PRF is prepared according to
low-speed centrifugation concept which provides a significant advantage for the
regeneration process, as it is rich in platelets, leucocytes and growth factors
thereby increasing vascularization.The other one is a minimally invasive
procedure Root plastique technique which is simple and time efficient, involves
the invasion of supra-crestal tissue attachment, the stimulation of bleeding.
This is performed to eliminate any obstacle to the ascent of the gingival
tissue and, at the same time, to create the space needed for the thickening of
the soft tissues, a space that was initially filled only by the blood clot.
This provides a concave space for the formation and stability of a blood clot
that will eventually lead to increased tissue thickness and keratinized tissue
width.Considering these two treatment modalities, the present study aims at
comparing the effectiveness of root plastique technique versus injectable PRF
as an adjunct to root plastique technique in subjects with NCCLs and recession. |