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CTRI Number  CTRI/2023/02/049705 [Registered on: 14/02/2023] Trial Registered Prospectively
Last Modified On: 06/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF PERICARDIUM MEMBRANE VERSUS A-PRF IN THE TREATMENT OF MULTIPLE GUM RECESSION  
Scientific Title of Study   COMPARISON OF PERICARDIUM MEMBRANE VERSUS A-PRF AS A SOFT TISSUE REGENERATIVE GRAFT IN THE TREATMENT OF GINGIVAL RECESSION USING TUNNEL TECHNIQUE: A RANDOMIZED SPLIT-MOUTH CLINICAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAATHVIKA RAMANI 
Designation  POSTGRADUATE STUDENT 
Affiliation  Meenakshi Ammal Dental College and Hospital.  
Address  Room no 7, Department of Periodontics, Faculty of Dental Sciences, Meenakshi Ammal Dental College and Hospital, #1, Alapakkam Main Road, Maduravoyal, Chennai.

Chennai
TAMIL NADU
600095
India 
Phone  9176421248  
Fax    
Email  satram1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SAATHVIKA RAMANI 
Designation  POSTGRADUATE STUDENT 
Affiliation  Meenakshi Ammal Dental College and Hospital.  
Address  Room no 7, Department of Periodontics, Faculty of Dental Sciences, Meenakshi Ammal Dental College and Hospital, #1, Alapakkam Main Road, Maduravoyal, Chennai.

Chennai
TAMIL NADU
600095
India 
Phone  9176421248  
Fax    
Email  satram1995@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijayalakshmi Rajaram  
Designation  Associate Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital.  
Address  Room no 7, Department of Periodontics, Faculty of Dental Sciences, Meenakshi Ammal Dental College and Hospital, #1, Alapakkam Main Road, Maduravoyal, Chennai.

Chennai
TAMIL NADU
600095.
India 
Phone  9444765440  
Fax    
Email  rajaramvijayalakshmi@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, Meenakshi Ammal Dental College and Hospital, #1, Alappakam Main Road, Maduravoyal, Chennai-95. 
Saathvika Ramani  
 
Primary Sponsor  
Name  Saathvika Ramani  
Address  Room no 7, Department of Periodontics, Faculty of Dental Sciences, Meenakshi Ammal Dental College and Hospital, #1, Alapakkam Main Road, Maduravoyal, Chennai -95 
Type of Sponsor  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 
Saathvika Ramani   Meenakshi Ammal Dental College and Hospital.  1st floor, Room No 7, Department of Periodontology, Meenakshi Amma Dental College and Hospital, #1, Alapakkam Main Road, Maduravoyal, Chennai.
Chennai
TAMIL NADU 
9176421248

satram1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Meenakshi Ammal Dental College and Hospital, Chennai.   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 
Comparator Agent  A-PRF  A-PRF membrane procured from the patients blood used as a regenerative graft for gingival recession management. Dose - A-PRF membrane is kept at the site, as per size of the recession defect. Frequency and duration of administration - only one single session.  
Intervention  Pericardium membrane (HEART - Bioteck S.p.A.)   Pericardium membrane used as a regenerative graft for gingival recession management. Dose is as per size of the recession defect, the membrane is cut and placed at the site. Frequency and duration of administration - only one single session.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Bilateral Miller’s class I and II multiple gingival recession defects 2.Gingival Recession depth  2mm
3. Gingival thickness > 1mm
4. Width of keratinised gingiva  2mm
5. Probing depth ≤3mm
6. Patients who maintain good oral hygiene
 
 
ExclusionCriteria 
Details  1. Recession defect associated with demineralization / caries, deep abrasion or restoration and teeth with evidence of pulpal pathology
2. Evidence of radiographic bone loss and periodontal disease.3. Previoushistoryofperiodontalsurgeryinthedefectareawithinpast1 year.
4. Usage of medications that interfere with healing.
5. Pregnancy and lactation
6. Alcoholics and Smokers
7. Systemically compromised patients 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the gingival recession depth, gingival recession width obtained with the use of Pericardium membrane on one side and A-PRF on contralateral side in the treatment of bilateral Miller’s class I and II multiple gingival recession defects using pouch and tunnel technique.  Baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the gingival thickness, keratinized gingiva width, probing pocket depth and clinical attachment level achieved with the use of Pericardium membrane on one side and A-PRF on contralateral side in the treatment of bilateral Miller’s class I and II multiple gingival recession defects using pouch and tunnel technique.  Baseline, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   20/02/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gingival recession is the exposure of root surface resulting from migration of gingival margin apical to the cementoenamel junction (CEJ). It may be localized or generalized and can be associated with one or more tooth surfaces. These patients would experience esthetic problems like receding gums and spacing between teeth or hypersensitivity. The key factor which determines the successful management of gingival recession is the identification of its etiological factors and their elimination. After the removal of etiologic factors, if problem persists it may require a variety of periodontal esthetic treatment modalities like root coverage procedures. The ultimate goal of any root coverage procedures is to cover the exposed root surfaces minimizing hypersensitivity and esthetically satisfy patient needs. 

A wide range of surgical techniques have been used in the management of gingival recession such as free gingival graft, pedicle flaps, laterally advanced flap, coronally advanced flap and subepithelial connective tissue graft. The above mentioned techniques can be combined along with EMD, non-resorbable and resorbable membranes, collagen matrix and platelet concentrates. 

A recent innovation is the use of third-generation platelet concentrate which is Advanced platelet-rich-fibrin (A-PRF) membrane which acts as a scaffold as well as accelerates wound healing due to its dense fibrin meshwork. The most recent advanced alternative is pericardium membrane which is known to contain essential growth factors and immunomodulatory factors that suppress inflammation and promote faster wound healing and periodontal regeneration. 

AIM OF THE STUDY: 

To evaluate the effectiveness of Pericardium membrane and A-PRF membrane as a soft tissue regenerative graft using pouch and tunnel technique in the treatment of bilateral Miller’s class I and II multiple gingival recession defects. 

OBJECTIVES OF THE STUDY:

The objective of this study is to compare the soft tissue regeneration and the increase in gingival biotype of bilateral Miller’s Class I and II gingival recession defects with the use of pericardium membrane with tunnel technique on one side and the use of A-PRF membrane with pouch and tunnel technique on the other side. 

 

STUDY DESIGN: Randomized Split-mouth clinical study. 

A total number of 10 patients with bilateral Miller’s class I and II multiple gingival recession defects in the anterior and premolar region of maxilla or mandible will be selected and divided into two groups using split-mouth design.


GROUP A10 sites will be treated with Pericardium membrane with tunnel technique

GROUP B10 sites will be treated with A-PRF membrane with tunnel technique.

 

STUDY PROTOCOL:  

After approval by the Ethical Committee for the study, the subjects will be selected from the out patients of Department of Periodontology, Faculty of Dentistry, Meenakshi Academy of Higher Education & Research Meenakshi Ammal Dental College, Chennai. The study sample consists of 10 systemically healthy subjects, both males and females, with Miller’s class I and II multiple gingival recession defects bilaterally in the anterior and premolar region of maxilla or mandible. The sites will be randomly allocated into two groups; group A and B based on inclusion and exclusion criteria. The written and informed consent will be obtained from each patient before enrolment in the study. 

1. RECESSION DEPTH (RD)

Instrument to be Used- Williams Periodontal Probe 

Technique- It is the measured distance from CEJ to the gingival margin at the mid-facial surface and rounded to the nearest millimeters. 

2. RECESSION WIDTH (RW)

Instrument to be Used- Williams Periodontal Probe 

Technique- measured distance between the mesial gingival margin & distal gingival margin at CEJ level. 

3. GINGIVAL THICKNESS (GT)

Instrument to be Used - Williams Periodontal Probe

Technique â€“ An endodontic reamer mounted with a silicone stopper will be perpendicularly inserted and the distance between the silicone stopper and the tip of reamer will be measured with a Vernier caliper.

  • 4. KERATINIZED GINGIVA WIDTH (KGW)

    Instrument to be Used - Williams Periodontal Probe

    Technique - It will be the measured distance from the free gingival margin to the mucogingival junction at the mid-facial surface and rounded to the nearest millimetres.

    5. PROBING POCKET DEPTH (PPD)

    Instrument To be Used - Williams Periodontal Probe

    Technique â€“ It is the measured distance from the gingival margin to the base of gingival sulcus at the mid-facial surface and rounded to the nearest millimeters.

    6. CLINICAL ATTACHMENT LEVEL (CAL)

    Instrument To be Used - Williams Periodontal Probe

    Technique - It is the measured distance from CEJ to the base of gingival crevice at the mid-facial surface and rounded to the nearest millimeters.

PHASE I THERAPY: 

Scaling and root planing will be performed. All clinical parameters will be recorded. These parameters will be assigned as the baseline measurements (Day 0). 


PRE-SURGICAL PROCEDURE:

PERICARDIUM MEMBRANE:

Heart®  is an equine origin pericardium membrane treated with Zymo-Teck®, the exclusive de-antigenation process based on the use of lytic enzymes. The membrane is biocompatible. Its long protection time of 3-4 months, high adhesiveness to the tissues, elastic and resistant nature , easily suturable property and durable barrier effect make it an ideal membrane for soft tissue regeneration. Prior to usage, the membrane is hydrated for 1-2 mins in sterile saline solution.

A-PRF PREPARATION (GHANAATI, 2014) :

Patient’s intravenous blood sample is taken without anticoagulant in 10 ml tubes which are immediately centrifuged at 1500 rpm for 14 minutes. A fibrin clot is then obtained in the middle of the tube, between the red corpuscles at the bottom and acellular plasma at the top. This is then compressed in the PRF box to form the A-PRF membrane. 

SURGICAL PROCEDURE: 

All the surgeries will be performed by the same examiner. The surgical sites will be randomly allocated to Group A and Group B by tossing the coin. The patients will be asked to perform a pre-procedural rinse with chlorhexidine gluconate (0.12%) for 1-2 mins and will be anesthetized using 2% Lignocaine HCl containing 1:80,000 adrenaline. With the help of No.15 blade, sulcular incisions will be given and tunnel will be prepared at the surgical site using tunnelling instruments. The tissues are gradually undermined including the base of the interdental papilla without interrupting the tip of the interdental papilla. The undermining should extend upto the Mucogingival Junction, so as to relax the flap and allow for the placement of the two membranes. 

In Group A, pericardium membrane will be placed in the prepared site. 

In Group B, A-PRF membrane will be placed in the prepared site. 

Both these membranes will be manipulated into the pouch and through the tunnel to cover the recipient site coronal to the cementoenamel junction. The tunnel is coronally advanced and sutured using 4-0 silk and composite stop and a periodontal dressing is placed. Patients will be given post-operative instructions: to avoid rinsing or spitting for 24 hours, to avoid brushing in the area of surgery for the following three days, to follow a soft diet during the first three days and to take the prescribed medications regularly. The patients will be prescribed a combination of Aceclofenac 100mg + Paracetamol 325mg twice daily for 3 days. 

POST- SURGICAL PROCEDURE: 

Patients will be recalled after 14 days for suture removal.

All patients will be placed on a strict maintenance schedule following suture removal and recalled at  90thday and 180th day. Oral hygiene will be checked and reinforced at each visit and all the clinical parameters will be recorded on  90th day and 180th day. 

 
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