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CTRI Number  CTRI/2024/04/066294 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assesing the comparative ability of Human epidermal growth factor and the Insulin-like growth factor-1 coated membranes in the treatment of receeding gums. 
Scientific Title of Study   Comparative evaluation of recombinant human epidermal growth factor and insulin like growth factor-1 coated membranes in the management of isolated millers class 1 gingval recession defects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Cheedella Anmisha 
Designation  Post graduate student  
Affiliation  Sibar Institute Of Dental Sciences 
Address  Department of Periodontics Room no: 8 2nd floor Sibar Institute Of Dental Sciences Takkellapadu Guntur 522509 ANDHRA PRADESH India

Guntur
ANDHRA PRADESH
522509
India 
Phone  8885388699  
Fax    
Email  anmishach9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaitanya Adurty 
Designation  Reader 
Affiliation  Sibar Institute Of Dental Sciences 
Address  Department of Periodontics Room no: 8 2nd floor Sibar Institute Of Dental Sciences Takkellapadu Guntur 522509 ANDHRA PRADESH India

Guntur
ANDHRA PRADESH
522509
India 
Phone  8142402848  
Fax    
Email  chaitanyaadurty@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chaitanya Adurty 
Designation  Reader 
Affiliation  Sibar Institute Of Dental Sciences 
Address  Department of Periodontics Room no: 8 2nd floor Sibar Institute Of Dental Sciences Takkellapadu Guntur 522509 ANDHRA PRADESH India


ANDHRA PRADESH
522509
India 
Phone  8142402848  
Fax    
Email  chaitanyaadurty@gmail.com  
 
Source of Monetary or Material Support  
Sibar Institute Of Dental Sciences Room no : 8 2nd floor Department Of Periodontics Takkellapadu Guntur 522509 
 
Primary Sponsor  
Name  Sibar Institute of Dental Sciences 
Address  Department Of Periodontics Room no: 8 2nd Floor Sibar Institute Of Dental Sciences Takkellapadu Guntur 522509  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Cheedella Anmisha  Sibar Institute Of Dental Sciences.  Room no.8 2nd floor Takkellapadu Guntur 522509
Guntur
ANDHRA PRADESH 
8885388699

anmishach9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sibar institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  class 1 Gingival Recession  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin like Growth factor-1 coated membrane   Treatment of millers class 1 Gingival recession defects using coronally advanced flap in combination with Insulin like Growth factor-1 coated membrane and followed up for a period of 6 months. 
Comparator Agent  Recombinant human Epidermal Growth Factor coated membrane   Treatment of millers class 1 Gingival recession defects using coronally advanced flap in combination with Epidermal growth factor coated membrane and followed up for a period of 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Age group 18-45 years.
2.Subjects who are apparently healthy.
3.Presence of Miller’s Class I gingival recession.
4.Width of keratinized gingiva (KGW) ≥2 mm.
5.Presence of identifiable Cemento-Enamel Junction (CEJ).
6.Subjects who are willing to give informed consent.
 
 
ExclusionCriteria 
Details  1.Subjects under medication.
2.Wasting diseases.
3.Presence of caries, furcations involvement in isolated gingival recessions.
4.Pregnant or lactating females.
5.Any form of Tobacco users.
6.Subjects with Tooth mobility.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Keratinized Gingival Width (KGW)
Wound Healing Index (WHI)
Percentage of Root Coverage (PRC) 
baseline,2 weeks, 3 months,6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Probing Depth (PD)
Clinical Attachment Level (CAL)
Recession Depth (RD)
Recession Width (RW)
Gingival Thickness (GT)

 
baseline, 3 months,6 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) 30/01/2026 
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  

Ø  Gingival recession (GR) is defined as the partial denudation of the root surface due to the apical migration of the soft tissue to the cemento–enamel junction (CEJ). As a result of recessions, there will be loss of support and exposure of root surface which will be resulting in plaque retention, gingival bleeding, abrasion and pain due to cervical dentin hypersensitivity, root caries and fear of tooth loss.To promote regeneration, the idea of excluding the gingival epithelium with just barrier membranes has evolved to include the incorporation of the right signaling molecules, such as growth factors directly into the wound.Epidermal growth factor (EGF) promotes epidermal cell renewal and is crucial to the healing process for wounds, thus the application of recombinant human epidermal growth factor (rh EGF) impregnated in collagen membrane might yield more favorable root coverage results.Insulin like growth factor -1(IGF-I) is able to prevent apoptosis in fibroblasts, to regulate DNA and protein synthesis in periodontal ligament fibroblasts in vitro and to enhance soft tissue wound healing

    SURGICAL PROCEDURE:All patients will be treated using the following surgical protocol. 60 sec pre-operative rinse with 0.2% chlorhexidine and local administration of 2% lignocaine with adrenaline at a concentration of 1:80000. In Group I and Group II an intrasulcular incision will be made at the buccal aspect of the involved tooth. Two horizontal incisions will be made at right angles to the adjacent interdental papillae, at the level of the CEJ, without interfering with the gingival margin of the neighboring teeth.Two oblique vertical incisions will be extended beyond the mucogingival junction, and a trapezoidal partial thickness flap will be raised and extended apically beyond the mucogingival junction, releasing the tension and favouring the coronal positioning of the flap.The epithelium on the adjacent papillae will be de-epithelized. The exposed root surface of tooth will be planed with the help of curettes.Following this, entire surgical area will be irrigated profusely with normal saline.On the test site in Group I, coronally advanced flap will be done, with collagen barrier membrane Impregnated with EGF will be placement just apical to the cementoenamel junction. The flap will be advanced coronally 2mm above CEJ. Sling sutures were placed to secure the flap in coronal position, and interrupted sutures, for vertical incisions. The surgical area should be protected and covered with a periodontal dressing. In Group II coronally advanced flap will be done, with collagen barrier membrane impregnated with IGF-1 will be placed just apical to the cemento enamel junction. The flap will be sutured coronally with 4-0 silk suture, and patients will be given instructions for gentle brushing with a soft toothbrush. Each patient will be instructed for proper oral hygiene measures postoperatively. Wound healing index will be recorded after 2 weeks of surgery, Clinical and Recession parameters will be recorded at 3 months and 6 months. At each visit, oral hygiene instructions will be reinforced and the surgical sites will be irrigated with normal saline.

    POST-OPERATIVE CARE:The patient will be instructed not to remove the pack on the surgical site until the sutures are removed. Antibiotics and analgesics will be prescribed. The use of 0.2% Chlorhexidine for additional 2 weeks will be advised. After 10 days, the periodontal dressing and the sutures will be removed and the oral hygiene instructions will be emphasized.

     FOLLOWUP VISITS:  3 months and 6 months.

 
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