FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049853 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 17/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison of the efficacy of placental membranes with bone grafts in the treatment of receeding gums. 
Scientific Title of Study   A comparative evaluation of the efficacy of amniotic membrane and chorion membrane along with demineralized freeze-dried bone allograft using coronally advanced flap technique in the treatment of millers class I and class II gingival recession defects - A 24 weeks clinical and radiological study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neeru Verma 
Designation  Post Graduate Student 
Affiliation  Inderprastha Dental College and Hospital, Uttar Pradesh 
Address  second floor, Room No 2 , Department of Periodontology, Inderprastha Dental College and hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  8802535729  
Fax    
Email  drneeruvermachoudhary@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pragya Tripathi 
Designation  Professor 
Affiliation  Inderprastha Dental College and Hospital, Uttar Pradesh 
Address  second floor, Room No 2 , Department of Periodontology, Inderprastha Dental College and hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9999977571  
Fax    
Email  dr.pragya.trip@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram Blaggana 
Designation  Head Of The Department (Department of Periodontology) 
Affiliation  Inderprastha Dental College and Hospital, Uttar Pradesh 
Address  second floor, Room No 2 , Department of Periodontology, Inderprastha Dental College and hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9811773797  
Fax    
Email  drblaggana@gmail.com  
 
Source of Monetary or Material Support  
Inderprastha dental college and hospital, Industrial 46/1 Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010 
 
Primary Sponsor  
Name  Dr Neeru Verma  
Address  Second floor, Department of Periodontology, Inderprastha Dental College and hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010 
Type of Sponsor  Other [other(self)] 
 
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 Neeru Verma  Inderprastha Dental college and Hospital  Second floor, Room no 2 department of periodontology Inderprastha dental college and hospital, 46/1 Sahibabad industrial area site 4 , ghaziabad
Ghaziabad
UTTAR PRADESH 
8802535729

drneeruvermachoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE  Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amniotic membrane and Demineralised freeze dried bone allograft(DFDBA) on one arm  Amniotic membrane in the size of 2x2.5sq centimeter will be placed at baseline i.e only one time during the surgical procedure. 2-3 grams of DFDBA in particle size 500-1040 micrometer will be placed at baseline, i.e. only once during the entire study  
Comparator Agent  Chorion membrane with Demineralised freeze dried bone allograft(DFDBA) in other arm  Chorion membrane in the size of 2x2.5sq centimeter placed over the recession area, at baseline i.e only one time, during the surgical procedure 2-3 grams of DFDBA in particle size 500-1040 micrometer will be placed only at baseline i.e one time during the surgical procedure  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  patients maintaining good oral hygiene with plaque index < 1.
Patients willing to participate in the study by giving written consent.
Systemically healthy patients with class1 and class 2 gingival recession. 
 
ExclusionCriteria 
Details  Debilitating systemic or infectious disease or any disease that affects the periodontium.
Known allergy to any of the materials used in the study.
Poor compliance.
Pregnancy or lactating women.
Use of tobacco products or immunosuppressant drugs
or corticosteroids.
History of previous root coverage procedures.
Patient undergoing orthodontic treatment.
Patients under anticoagulant treatment.
Patients with caries and restoration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in clinical parameters of probing depth and soft tissue volume  12 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The buccal bone level is expected to increase.  24 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   21/02/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   AIM: Therefore the aim of the study is to compare and evaluate the efficacy of amniotic membrane  with DFDBA versus  chorion membrane with DFDBA using coronally advanced flap technique in the treatment of  Miller’s class I and class II gingival recession defects clinically and radiologically.

METHODOLOGY:  

PRE SURGICAL PROCEDURE

—  Routine laboratory blood investigations will be carried out.

—  Phase l therapy, that will include oral hygiene instructions, scaling and root planing using hand and ultrasonic instruments, will be performed.

—  The CBCT measurements will be taken for each group i.e. Group A (Amniotic membrane and DFDBA) and Group B (Chorion membrane and DFDBA) at baseline and 24 weeks.

—  Patients will be re-evaluated 3-4 weeks after phase l therapy for plaque maintenance.

—  Patient with Plaque index39 score <1.0 will be included in the study.

—  Appropriate antibiotic prophylaxis will be given to the patient before surgery.

  

SURGICAL TECHNIQUE

—  All surgical procedures will be carried out by one operator.

—  The sites will be randomly assigned to Group A or Group B through a computer generated data and will be assigned of either of the two groups before surgery.

—  CAF was advocated utilizing the method depicted by Pini-Prato et al.

—  The surgical area will be anaesthetised using 2% lignocaine hydrochloride containing 1:80,000 epinephrine. Before the elevation of the flap, both the exposed root surfaces will be gently planed with sharp Gracey curette to reduce root convexity. Immediately after, root conditioning will be done with 24% EDTA for 2-3 minutes41 followed by copious irrigation with normal saline for 30-60 seconds.

—  Intrasulcular incisions will be given with B P blade (no.15) on the buccal aspect of the involved tooth. This incision will be horizontally extended to the adjacent papillae avoiding the gingival margin of the adjacent teeth. Two vertical releasing incisions will be carried out from the mesial, and distal extremities of the horizontal incision sufficiently beyond the mucogingival junction.

·         A trapezoidal full�’ thickness flap will be raised with a periosteal elevator, 3-4mm beyond the apical crest of osseous dehiscence. Then a partial�’ thickness dissection will be carried out apically leaving the underlying periosteum in place.

—  In Group A amniotic membrane and DFDBA will be placed and the flap will be advanced coronally where as in Group B chorion membrane and  DFDBA will be placed followed by coronal flap advancement.

—  Suturing will be performed with 4-0 vicryl suture to secure the flap and membrane at the required position.

 

POST SURGICAL CARE:

—  Suitable antibiotic and analgesic will be prescribed for 5 to 7 days.

—  Patient will be advised to rinse with 0.2% chlorhexidine digluconate twice a day for 2 weeks following surgery.

—  Periodontal dressing and sutures will be removed 7-14 days after surgery.

—  Post operative instructions and patient will be reinstructed to maintain oral hygiene.

—  Each patient will be revaluated for periodontal maintenance and clinical parameters at 12 weeks and 24 weeks post operative will be recorded.

—  CBCT measurements will be recorded for each group i.e. Amniotic membrane and DFDBA group and Chorion membrane and DFDBA group after 6 months.

 
Close