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Gingival RecessionNCT04195737

Comparison of Coronally Advanced Root Coverage Procedure With Collagen Matrix and Connective Tissue Graft

A study testing Ossix volumax collagen matrix and Connective Tissue Graft in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a coronally advanced flap with ossix volumaxTM collagen matrix and connective tissue graft in the treatment of multiple adjacent gingival recession defects. Read more about this study

Who is it for?
Ages 18 to 58 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Ossix volumax collagen matrix and Connective Tissue Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndia
Study dates
12 Dec 2019to 6 Aug 2021
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 58 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age greater than or equal to18 years.
  • Multiple adjacent Miller's class I and class II gingival recession sites.
  • Patients with healthy or treated periodontal conditions.
  • Patients with esthetic concerns.
  • Absence of uncontrolled medical conditions.
  • Full mouth plaque score </= 10% (O'Leary 1972)
  • Full mouth bleeding score <10% (Ainamo and Bay 1975)

Who cannot join

  • Gingival biotype less than 0.8 mm.
  • Pregnant or lactating females.
  • Tobacco smoking.
  • Untreated periodontal conditions.
  • Use of systemic antibiotics in the past 3 months.
  • Patients treated with any medication known to cause gingival hyperplasia

Trial locations and contacts

1 site in 1 country.

India1 site
  • Krishnadevaraya college of dental sciences

    Bangalore, Karnataka, 562157

Other trials in India

About this study

Official title: Comparative Evaluation of Coronally Advanced Root Coverage Procedure With Ossix Volumax™ Collagen Matrix and Connective Tissue Graft-Randomized Controlled Trial

The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a coronally advanced flap with ossix volumaxTM collagen matrix and connective tissue graft in the treatment of multiple adjacent gingival recession defects.

The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Read the detailed description

Periodontal plastic surgery are surgical procedures performed to prevent or correct anatomic, developmental, traumatic or disease-induced defects of the gingiva, alveolar mucosa or bone. It includes various soft and hard tissue procedures aimed at gingival augmentation, root coverage, correction of mucosal defects at implants, crown lengthening, gingival preservation at ectopic tooth eruption, removal of aberrant frena, prevention of ridge collapse associated with tooth extraction and augmentation of the edentulous ridge.1

Different predisposing anatomic features can result in recession such as position and anatomy of teeth in the dental arch, bony dehiscence, thickness of the alveolar mucosa, muscle pull, orthodontic treatment, thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, abnormal frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.2 The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear. Treatment modalities for gingival recession have many influencing factors such as defect dimensions (depth, width), site (maxilla, mandible), defect number (single, multiple), soft tissue anatomy (keratinized tissue quality/quantity; papilla height/width; frenum/ muscle pull; vestibular depth) tooth position etc.

Various surgical techniques for the treatment of recessions includes the use of full or partial thickness flap with various soft tissue grafts such as epithelized free gingival grafts (FGG) or sub-epithelial connective tissue graft (SCTG) in conjunction with various types of flaps eg: (envelope, coronally or laterally positioned flap, double pedicle flap (DPF) or tunnelling (TUN) alone or combined with laterally positioned pedicle flaps (LPPF).3 Coronally advanced flap (CAF) with connective tissue graft (CTG) is considered as the gold standard treatment for gingival recession. Commercially available materials for root coverage are expanded Poly Tetra Fluoro Ethylene (Gore-Tex), polglactin, Collagen membranes like biogide, biomend, resolute, alloderm, collatape etc, collagen matrix such as mucograft, human amniotic membrane, dermagraft, ossix.4

Recently in a case report using platelet concentrate carried on collagen sponge (ossix) showed favourable results.4 Ossix volumax™ has shown De novo bone formation when used in alveolar ridge augmentation procedure.5

Ossix volumax™ (Datum dental) is one such recently identified sugar cross-linked bio programmed collagen matrix. Ossix volumax™ is a volumizing, thick collagen scaffold, featuring glymatrix technology. The properties are thick and expand when wet, excellent handling, easy to use, adapts and adheres to the bone.5 It undergoes rapid ossification (in CT scans and histology after one month).6

Literature search till date has shown no studies regarding the use of type 1 sugar cross-linked collagen membrane for treatment of gingival recession. So, the present study is undertaken with the aim to comparatively evaluate the advantages of ossix volumax collagen membrane with subepithelial connective tissue graft for the treatment of multiple adjacent gingival recession defects.

Being tested
Ossix volumax collagen matrix, Connective Tissue Graft
Keywords
Gingival Recession Coverage
Medical subject headings
Gingival Recession

What participants receive

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

  • Ossix volumax collagen matrixProcedure or surgery

    Under LA horizontal incision is made.Split-full-split thickness flap is elevated.The remaining soft tissue of the anatomic interdental papillae deepithelialized.Coronal advancement of the flap obtained and closed using sling suture.

  • Connective Tissue GraftProcedure or surgery

    Under LA parallel incisions is made 1-2 mm first molar to canine.Graft incision 1 mm coronal to the horizontal flap incision.Through this incision designed graft thickness is obtained.The graft obtained between the two horizontal incisions has a 1 mm coronal strip that require depithelisation with a knife and closed using interrupted suture.

Study groups in NCT04195737
Study groupRoleWhat they receive
Root coverage with ossix volumax collagen matrixExperimentalEvaluation of root coverage achieved by collagen matrix in conjunction with coronally advanced flap in patients with multiple gingival recession.
Receives: Procedure: Ossix volumax collagen matrix
Root coverage with connective tissue graftActive comparatorEvaluation of root coverage achieved by connective tissue graft in conjunction with coronally advanced flap in patients with multiple gingival recession
Receives: Procedure: Connective Tissue Graft

What is being measured

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

  1. gingival recession depth

    measured as the distance from the CEJ to the gingival margin.

    Measured: 6 months

  2. Complete root coverage

    root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction

    Measured: 6 months

  3. Mean root coverage

    (Baseline recession depth - 6 month recession depth/Baseline recession depth)*100

    Measured: 6 months

Secondary outcomes (9)
  1. pocket Probing depth

    measured as the distance from the gingival margin to the base of gingival sulcus

    Measured: 6 months

  2. Gingival Recession width

    measured as the distance between the mesial gingival margin and distal gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction).

    Measured: 6 months

  3. Clinical attachment level

    measured as Gingival Recession Depth + Probing Depth

    Measured: 6 months

  4. Gingival biotype thickness

    measured 3mm apically from the free gingival margin at the mid buccal aspect of the tooth.

    Measured: 6 months

  5. Apico-coronal width of keratinized tissue

    ) measured as the distance from the mucogingival junction to the gingival margin,with the mucogingival junction location determined using (Schiller's Potassium Iodide Solution).

    Measured: 6 months

  6. Root coverage esthetic score

    The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES).

    Five Variables evaluated which are as follows:

    Level of Gingival margin (GM) Marginal Tissue Contour (MTC) Soft Tissue Texture (STT) Mucogingival Junction(MJ) alignment Gingival Colour (GC) The values ranges between 0 - 6.Higher the value better is the outcome.

    Measured: 6 months

  7. Plaque index

    It is measured by using UNC 15 probe.The values lie between 0 - 3.Higher the outcome the prognosis will be poor.

    Measured: 6 months

  8. Gingival index

    It is measured by using UNC 15 probe.The values lie between 0 - 3.Higher the outcome the prognosis will be poor.

    Measured: 6 months

  9. Gingival Bleeding index

    It is measured by using UNC 15 probe.The values lie between 0 - 1. And presence or absence of bleeding is evaluated.

    Measured: 6 months

Timeline

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

  1. First posted12 Dec 2019
  2. Study start12 Dec 2019
  3. Primary completion17 Jul 2021
  4. Study completion6 Aug 2021

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
Model description
Two groups were made one test and control. The test group will be treated with coronally advanced flap with ossix volumax™ collagen matrix and control group will be treated with coronally advanced flap with Sub epitheial Connective Tissue Graft.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04195737
Sponsor's protocol ID
02_D012_100209
Status last verified
Mar 2023
First submitted
10 Dec 2019
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ossix volumax collagen matrix and Connective Tissue Graft in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gingival recession depth (time frame: 6 months). The study lists 3 primary outcomes in all. 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 27 Mar 2023.

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