COMPARISON OF PERICARDIUM MEMBRANE VERSUS A-PRF IN THE TREATMENT OF MULTIPLE GUM RECESSION
- Conditions
- Chronic periodontitis,
- Registration Number
- CTRI/2023/02/049705
- Lead Sponsor
- Saathvika Ramani
- 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 A**: 10 sites will be treated with Pericardium membrane with tunnel technique.
**GROUP B**: 10 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 – 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 – 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
- Usage of medications that interfere with healing.
- Pregnancy and lactation 6.
- Alcoholics and Smokers 7.
- Systemically compromised patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Meenakshi Ammal Dental College and Hospital.
🇮🇳Chennai, TAMIL NADU, India
Meenakshi Ammal Dental College and Hospital.🇮🇳Chennai, TAMIL NADU, IndiaSaathvika RamaniPrincipal investigator9176421248satram1995@gmail.com