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Gingival RecessionNCT05568732

Evaluation of Volume Stable Collagen Matrix in RT2 Gingival Recession Compared to Connective Tissue Graft

A study testing Root coverage procedure will be done with VCMX and Root coverage procedure will be done with CTG in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gingival recession is the migration of the gingiva to a point apical to the cemento-enamel junction. In order to treat challenging miller class 3 or RT2 recessions, several mucogingival approaches have been proposed. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Root coverage procedure will be done with VCMX and Root coverage procedure will be done with CTG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndia
Study dates
15 Oct 2022to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. Patients with Millers class3[4] or RT2[6] isolated recession defects in labial mandibular anterior teeth region.
  • 2. Systemically healthy individuals.
  • 3. Absence of clinical tooth mobility.
  • 4. Age 18-45 years old.
  • 5. A full mouth plaque index < 20%
  • 6. Patient showing adequate compliance and willing to participate in the study.

Who cannot join

  • Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
  • Previous surgical attempt to correct gingival recession.
  • Crowding of affected teeth.
  • Patients with active periodontal disease.
  • Smokers and tobacco users.

Trial locations and contacts

1 site in 1 country.

SHIKHA TEWARI, MDS contact

9416514600

drshikhatewari@yahoo.com

India1 site, 1 recruiting
  • Post Graduate Institute Of Dental Science

    Rohtak, Haryana, 124001

    Sanjay Tewari, 01262283876, principalpgids@yahoo.in

    Ambika Gupta

    Recruiting

Other trials in India

About this study

Official title: Comparative Evaluation of Treatment Outcome of Volume Stable Collagen Matrix in Isolated Labial rt2 Gingival Recession as Compared to Subepithelial Connective Tissue Graft : a Randomized Controlled Clinical Trial.

Gingival recession is the migration of the gingiva to a point apical to the cemento-enamel junction. In order to treat challenging miller class 3 or RT2 recessions, several mucogingival approaches have been proposed. The subepithelial connective tissue graft (CTG) combined with a coronally advanced flap (CAF) has been considered as the "gold standard" for recession coverage around teeth. However, significant resorption of CT graft material has been reported if the graft material is exposed. And that can reduce the possibility of complete root coverage. volume stable collagen matrix - (VCMX ) is a volume stable, fully resorbable, porous, collagen matrix of porcine origin and spongious consistency and is one of the most biocompatible, novel material to be used in this study. VCMX of porcine origin is predominantly made of collagen type I and III and a small portion of elastin. VCMX is able to overcome the volume stability limitation of most commercially available grafts. The surgical technique proposed in a case series using a volume-stable collagen matrix and autogenous subepithelial CTG may be an effective method for periodontal biotype modification through thickening of the entire facial aspect for the treatment of gingival recession. VCMX consists of a single porous layer with interconnected pores (93% volume porosity) and an average pore size of 92 µm. While mechanical stability is achieved by chemical crosslinking, mechanical testing demonstrated preserved elasticity of the material over 14 days. Data have convincingly demonstrated enhanced promigratory and proadhesive properties of three primary cell types human oral fibroblas(hOFs) and human umblical vein endothelial cells(HUVECs), grown on the VCMX. The VCMX was characterized with an efficient adsorption of four recombinant growth factors (TGF-β, PDGF-BB, FGF-2, and GDF-5), naturally present in the blood clot. And in a RCT with Miller's class 1 and 2 it also showed that it provides volume stability and withstands early resorption, while encouraging formation of new soft tissue. Due to its wettability, suture-ability and biological properties, the device has been reported to become well integrated with surrounding soft tissue. No study has been evident on comparing VCMX and SCTG for Miller's class 3/RT2 recession defect. Therefore the purpose of the study is to compare the clinical outcome of VCMX ans SCTG in Miller's class 3/RT2 .

Read the detailed description

Gingival recession is the migration of the gingiva to a point apical to the cemento-enamel junction. In routine dental practice gingival recession defects are frequently encountered complain because of functional and esthetic concern of patients . Indications of root coverage procedures including esthetics, defect progression, hypersensitivity, or difficulties with oral hygiene support the use of periodontal plastic surgical procedures.

Miller in 1985 proposed a classification system which is probably the most commonly employed system to classify gingival recession and divided it into four categories. Class III recession extends to or beyond the MGJ with bone or soft tissue loss in the interdental area, or there is malpositioning of the teeth which may be a hinderance to complete root coverage and hence partial root coverage can be expected. According to Cairo (2011), Recession Type 2 (RT2): Gingival recession associated with loss of interproximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket) .

The subepithelial connective tissue graft (CTG) combined with a coronally advanced flap (CAF) has been considered as the "gold standard" for recession coverage around teeth, Harvesting of SECTG can be done from the palate, maxillary tuberosity or edentulous ridges. The palate remains the most common donor site. The harvesting of SECTGs produces less postoperative morbidity than free gingival grafts. Many modifications of the techniques to harvest SECTGs have been proposed, each subtly different from each other in the number of incisions, flap design, and technique. Hurzeler suggested a single incision technique to harvest SECTG, with advantages of healing with primary intention at the donor site and very less postoperative morbidity to the patient but in the quest for easier to use, unlimited supply alternatives to painful harvest grafts, researchers continue to test harvest graft substitute. However, the harvesting procedure is classified as being difficult and may be associated with the risk of intra and postoperative complications such as bleeding, infection or necrosis. Several studies have focused on alternatives including human dermis and collagen matrices(CMX). A multicentre trial in isolated recessions indicated that the addition of CMX to coronally advanced flap resulted in a significant benefit in terms of marginal soft tissue thickness and patient-reported outcomes compared to coronally advanced flaps alone.The results, however, failed to support the non-inferiority hypothesis of CMX with respect to CTG in terms of root coverage. Now, a volume stable, fully resorbable, porous, collagen matrix of porcine origin and spongious consistency (volume stable collagen matrix - VCMX ) has become available for soft tissue augmentation. The surgical technique proposed in a case series using a volume-stable collagen matrix and autogenous subepithelial CTG may be an effective method for periodontal phenotype modification through thickening of the entire facial aspect for the treatment of gingival recession. In a Randomized clinical trial(RCT), it showed that VCMX provides volume stability and withstands early resorption, while encouraging formation of new soft tissue. Due to its wettability, suture ability and biological properties, the device has been reported to become well integrated with surrounding soft tissue.

Given these characteristics, this study will be conducted to evaluate the root coverage % in Miller's class 3 or RT2 gingival recession in mandibular anterior teeth using a VCMX compared to CTG with minimally invasive access technique.

The present randomized controlled clinical trial will be conducted in the department of Periodontics and Implantology, Post Graduate Institute of Dental Sciences, Rohtak. Study design is of 12-14 months. Patients will be recruited from the outpatient department of periodontology. It will be divided into Test group - VCMX Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with VCMX using minimally invasive access technique and Control group - CTG Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

Full mouth scaling and root planing will be performed using ultrasonic and hand instruments as needed.

After administration of local anaesthesia, exposed root surface will be scaled and planned using curettes. With a minimally invasive access technique a full thickness tunnel will be prepared with the aid of specific tunnelling instruments, extending it sufficiently beyond the mucogingival line into alveolar mucosa. This will be done to completely releasing the tunnel-papillae complex, thus facilitating its passive coronal replacement.

CTG will be procured from the palate or tuberosity area for root coverage procedure by single incision technique. The template will be placed on the palate to mark the extent of the graft, after local anesthesia was administered. The palatal wound will be sutured to obtain primary wound closure. VCMX was thinned and cut to size for the defect, rounding and sloping the matrix edges so they were thinner around the perimeter. In test group, Volume-stable collagen matrix will be placed and in control group only CTG will be placed.

Suitable antibiotics and analgesics will be prescribed for 5 days. Chlorhexidine (0.12%) mouthwash will be advised till suture removal. The dressing and sutures will be removed after 7-10 days. Instructions will be given for gentle brushing with a soft toothbrush and reinstructed for proper oral hygiene maintenance.

The patient will be recalled for examination weekly for upto 1 month after surgery and again at 3, 6 and 9 months.

After enrollment, participants will be instructed about oral hygiene maintainance and undergo nonsurgical periodontal treatment in the form of scaling and root planing. All baseline parameters will be recorded 4-6 weeks after SRP after once gingival inflammation is resolved. Placement of VCMX will be done in the Test group and participants will be recalled after 3 months for recording all parameters. Among the control group participants, CTG will be placed after resolution of gingival inflammation ( 4-6 weeks after SRP ). Both groups will be re-evaluated and undergo recording of all parameters at the end of final treatment.

Being tested
Root coverage procedure will be done with VCMX, Root coverage procedure will be done with CTG
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Root coverage procedure will be done with VCMXProcedure or surgery

    Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with VCMX using minimally invasive access technique.

  • Root coverage procedure will be done with CTGProcedure or surgery

    Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

Study groups in NCT05568732
Study groupRoleWhat they receive
Test groupExperimentalScaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with VCMX using minimally invasive access technique.
Receives: Procedure: Root coverage procedure will be done with VCMX
Control groupActive comparatorScaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.
Receives: Procedure: Root coverage procedure will be done with CTG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Root coverage percentage

    Percentage of root coverage will be calculated by using pre and post operative recession depth

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start15 Oct 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05568732
Sponsor's protocol ID
vaishali pagade perio 22/29
Status last verified
Jan 2023
First submitted
3 Oct 2022
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Root coverage procedure will be done with VCMX and Root coverage procedure will be done with CTG in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact SHIKHA TEWARI, MDS (9416514600, drshikhatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root coverage percentage (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

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