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Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 22:58:46 GMT)

CTRI Number CTRI/2020/05/024998 [Registered on: 04/05/2020] - Trial Registered Prospectively Last Modified On 02/05/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Surgical/Anesthesia Dentistry Study Design Randomized, Parallel Group Trial Public Title of Study A clinical trial to study the clinical outcome of connective tissue graft with and without iPRF in combination with coronally advanced flap Scientific Title of COMPARATIVE EVALUATION OF SUBEPITHELIAL CONNECTIVE TISSUE GRAFT WITH AND Study WITHOUT INJECTABLE PLATELET RICH FIBRIN IN THE TREATMENT OF GINGIVAL RECESSION: A CLINICAL STUDY Secondary IDs if Any Secondary ID Identifier U1111-1248-4785 UTN Details of Principal Details of Principal Investigator Investigator or overall Name Jyotsna Trial Coordinator (multi-center study) Designation Post Graduate Student Affiliation SDM College of Dental Sciences, Address Dept of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital, Sattur, Dharwad Dept of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital, Sattur, Dharwad Dharwad 580009 Phone 9972832438 Fax 0836-2467612 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Jyotsna Kusugal Query) Designation Post Graduate Student Affiliation SDM College of Dental Sciences, Dharwad Address Dept of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital, Sattur, Dharwad Dept of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital, Sattur, Dharwad Dharwad KARNATAKA 580009 India Phone 9972832438 Fax 0836-2467612 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Swati Setty Designation Professor and Head Affiliation SDM College of Dental Sciences, Dharwad Address Dept of Periodontics and Oral Implantology, SDM College of Dental

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Sciences and Hospital, Sattur, Dharwad Dept of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital, Sattur, Dharwad Dharwad KARNATAKA 580009 India Phone 9845680773 Fax 0836-2467612 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Department of Periodontics and Oral Implantology, SDM College of Dental Sciences, Dharwad Primary Sponsor Primary Sponsor Details Name Dr Jyotsna Kusugal Address Post Graduate Student, Department of Periodontics and Oral Implantology, SDM College of Dental Sciences, Dharwad Type of Sponsor Other [self] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Jyotsna Kusugal SDM College of Dental Dept of Periodontics 0836-2468142 Sciences and Hospital and Oral Implantology, 0836-2467612 SDM College of Dental [email protected] Sciences and Hospital, Sattur, Dharwad Dharwad KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? SDM College of Dental Approved 15/11/2018 No Sciences Hospital- Institutional Ethical Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Gingival recession Intervention / Type Name Details Comparator Agent Intervention Recession coverage surgery Informed consent will be taken using subepithelial connective from all the participants tissue graft registered in the study after explanation of the procedure in detail. The study will be carried out on 12 teeth having Miller Class I and Class II recession. Before surgery, all the participants will receive initial periodontal therapy including scaling and root planing and

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oral hygiene instructions. They will be re-evaluated at 7 days after initial therapy and participants with full-mouth plaque score less than 20 percent and full mouth bleeding score less than 20 percent will be scheduled for the surgical procedure. Then they will be categorized into two groups. In the first group (Group A) primary incisions will be made in mesial and distal directions from cemento-enamel junction upto 2mm of the proximal line angle of the adjacent teeth leaving the interdental papilla intact. Through an undermining full thickness incision, flap will be elevated around the denuded root surface. A measurement of the approximate length and width of the graft required will be obtained using UNC-15 (Hu-friedy) probe. Subepithelial Connective Tissue Graft will be harvested from the palate. Sutures will be placed on the donor area. The graft will be immediately transferred to the recipient site completely covering the formerly exposed root area. Firm pressure will then be applied on the graft with a sterile moist gauze pack for 3-5 minutes to aid the graft to adapt and adhere to the recipient bed. The graft will be secured in position with suture. The overlying flap will be advanced coronally and sutured. Then the periodontal dressing will be placed. Intervention Recession coverage surgery Informed consent will be taken using subepithelial connective from all the participants tissue graft combined with registered in the study after injectable- platelet rich fibrin explanation of the procedure in detail. The study will be carried out on 12 teeth having Miller Class I and Class II recession. Before surgery, all the participants will receive initial periodontal therapy including scaling and root planing and oral hygiene instructions. They will be re-evaluated at 7 days after initial therapy and participants with full-mouth plaque score less than 20 percent and full mouth bleeding score less than 20 percent will

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be scheduled for the surgical procedure. Then they will be categorized into two groups. In the second group (Group B) primary incisions will be made in mesial and distal directions from cemento-enamel junction upto 2mm of the proximal line angle of the adjacent teeth leaving the interdental papilla intact. Through an undermining full thickness incision, flap will be elevated around the denuded root surface. A measurement of the approximate length and width of the graft required will be obtained using UNC-15 (Hu-friedy) probe. Subepithelial Connective Tissue Graft will be harvested from the palate. Sutures will be placed on the donor area. 10ml of venous blood will be collected from participants in group B and it will be centrifuged immediately without an anticoagulant at 700rpm for 3 minutes to prepare injectable- platelet rich fibrin. The subepithelial connective tissue gratft will be combined with injectable- platelet rich fibrin before placement into recipient area. The graft will be immediately transferred to the recipient site completely covering the formerly exposed root area. Firm pressure will then be applied on the graft with a sterile moist gauze pack for 3-5 minutes to aid the graft to adapt and adhere to the recipient bed. The graft will be secured in position with suture. The overlying flap will be advanced coronally and sutured. Then the periodontal dressing will be placed. Comparator Agent Not applicable Not applicable Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) Gender Both Details 1. Both male and female participants aged 18 to 60 years.
2. Systemically healthy participants with no contraindications to periodontal surgery.
3. Teeth with isolated Miller’s Class I and Class II gingival recessions with ? 2mm width of keratinized tissue apical to the recession.
Exclusion Criteria Exclusion Criteria

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Details 1. Pregnant and lactating women. 2. Participants who have undergone any mucogingival procedures at the selected sites within the previous 3 months. 3. Systemic diseases that affect the periodontium. 4. Smokers and tobacco chewers. 5. Participants who will not be willing for participation in the study.

Method of Generating Computer generated randomization Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints This sudy is intended to evaluate and compare Baseline and 3 months the clinical outcome of subepithelial connective tissue graft (SCTG) with and without injectable platelet rich fibrin (i-PRF) in conjunction with coronally advanced flap (CAF) for Miller’s class I and class II gingival recessions. Secondary Outcome Outcome Timepoints Nil Nil Target Sample Size Total Sample Size=24 Sample Size from India=24 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 04/05/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=8 Days=15 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil

Brief Summary One of the most common esthetic problem encountered in the field of periodontology is gingival rece/ssion which is perceived by the patients as increasing length of teeth. Root coverage procedures are often required to fulfill the esthetic demands, to facilitate plaque control and to treat the sensitivity of the exposed root surface. Numerous surgical procedures have been described to achieve root coverage (RC) such as coronally advanced flap (CAF), pedicle flaps, free gingival graft, subepithelial connective tissue graft (SCTG), guided tissue regeneration etc. It has been confirmed by many studies and systematic reviews that CAF procedure is a safe and reliable approach in periodontal plastic surgery and is associated with consistent recession reduction and frequently results in complete root coverage. Also CAF+SCTG has been accepted as the gold standard among various root coverage procedures. From the past two decades, with the introduction of second generation of platelet aggregates, platelet rich fibrin (PRF), a new era of regenerative materials has begun. and the recent addition to this list is the introduction of i-PRF. These platelet concentrates propose an acceleration in healing of soft and hard tissues by increasing the concentration of growth factors such as transforming growth factor-? (TGF-?), insulin-like growth factor-1 (IGF1), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), epidermal growth factor (EGF) and platelet-derived epidermal growth factor (PDEGF). To the best of our knowledge, there are no studies reporting the combined use of

SCTG and i-PRF and this study is probably the first of its kind. Thus, the purpose of this study is to compare the clinical outcome of SCTG with and without i-PRF in conjunction with CAF for Miller’s class I and II gingival recession.

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