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.
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
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.
- Conditions
- Gingival Recession
- 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 group | Role | What they receive |
|---|---|---|
| Root coverage with ossix volumax collagen matrix | Experimental | Evaluation 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 graft | Active comparator | Evaluation 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.
gingival recession depth
measured as the distance from the CEJ to the gingival margin.
Measured: 6 months
Complete root coverage
root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
Measured: 6 months
Mean root coverage
(Baseline recession depth - 6 month recession depth/Baseline recession depth)*100
Measured: 6 months
Secondary outcomes (9)
pocket Probing depth
measured as the distance from the gingival margin to the base of gingival sulcus
Measured: 6 months
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
Clinical attachment level
measured as Gingival Recession Depth + Probing Depth
Measured: 6 months
Gingival biotype thickness
measured 3mm apically from the free gingival margin at the mid buccal aspect of the tooth.
Measured: 6 months
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
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
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
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
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.
- First posted12 Dec 2019
- Study start12 Dec 2019
- Primary completion17 Jul 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prabhuji MLV, Study director, Krishnadevarya Dental College
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Coronally Advanced Root Coverage Procedure With Ossix Volumax™ Collagen Matrix and Connective Tissue Graft-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04195737
- Acronym / sponsor ID
- 02_D012_100209
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession Coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Root coverage with ossix volumax collagen matrix | Experimental | Procedure: Ossix volumax collagen matrixEvaluation of root coverage achieved by collagen matrix in conjunction with coronally advanced flap in patients with multiple gingival recession. |
| Root coverage with connective tissue graft | Active comparator | Procedure: Connective Tissue GraftEvaluation of root coverage achieved by connective tissue graft in conjunction with coronally advanced flap in patients with multiple gingival recession |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ossix volumax collagen matrixUnder 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. | Procedure or surgery | Root coverage with ossix volumax collagen matrix |
| Connective Tissue GraftUnder 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. | Procedure or surgery | Root coverage with connective tissue graft |
Primary outcome
gingival recession depth
Time frame: 6 months
measured as the distance from the CEJ to the gingival margin.
Complete root coverage
Time frame: 6 months
root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
Mean root coverage
Time frame: 6 months
(Baseline recession depth - 6 month recession depth/Baseline recession depth)*100
9 secondary outcomes
pocket Probing depth
Time frame: 6 months
Gingival Recession width
Time frame: 6 months
Clinical attachment level
Time frame: 6 months
Gingival biotype thickness
Time frame: 6 months
Apico-coronal width of keratinized tissue
Time frame: 6 months
Root coverage esthetic score
Time frame: 6 months
Plaque index
Time frame: 6 months
Gingival index
Time frame: 6 months
Gingival Bleeding index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prabhuji MLV study director
Krishnadevarya Dental College
1 site in 1 country: see every site and its status.
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.