| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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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
|
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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. |