| 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
|
|
|
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
|
|
|
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. |