Soft Tissue AugmentationNCT03753906
Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
A study testing Osmed® hydrogel expander implantation in people with Soft Tissue Augmentation, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
The present study is a human, prospective, single centre, single blind randomised controlled clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel expander (Osmed®) to gain keratinised tissue around the dentulous area. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation
- What is being tested?
- Osmed® hydrogel expander implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2016to Jan 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients willing to participate in the study
- Patients above 18 years of age
- Systemically healthy patients
- Patients exhibiting keratinized tissue width < 2 mm
- Patients manifesting Miller's Class I or Class II recession
- Patients who demonstrate good plaque control ( PI < 10% ) and showing good compliance
- Uncompromised adjacent teeth with healthy gingival conditions
Who cannot join
- Untreated periodontal disease, caries
- Insufficient oral hygiene
- Thin biotype ( < 0.8 mm )
- Use of tobacco
- Previous radiation therapy
- Patients with known systemic diseases and conditions as uncontrolled diabetes mellitus or haemorrhagic disorders
- Pregnant and lactating women
- Non-compliant patients
About this study
Official title: Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
The present study is a human, prospective, single centre, single blind randomised controlled clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Read the detailed description
Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.
All the patients were implanted with self-inflating hydrogel expander (Osmed®) in subperiosteal positions using the pouch technique in the mandibular anterior region. The clinical parameters were recorded at baseline, two weeks post expander retrieval, three months and six months post-operatively.
- Conditions
- Soft Tissue Augmentation
- Being tested
- Osmed® hydrogel expander implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osmed® hydrogel expander implantationDevice
Under local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Osmed® hydrogel expander implantation | Experimental | Implantation of Osmed® hydrogel expander was done in subperiosteal positions using the pouch technique in the mandibular anterior region. Receives: Device: Osmed® hydrogel expander implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized tissue width (KTW)
measured from the most apical gingival margin to the mucogingival junction (MGJ), with the MGJ location determined using the visual method (Schiller's potassium iodide solution).
Measured: 6 months
Keratinized tissue thickness (KTT)
measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.
Measured: 6 months
Optical scanning for analysis of tissue thickness
alginate impressions were made at the baseline prior to expander placement, immediately after the removal of expander and 6 months post-augmentation. The prepared casts were assessed for soft tissue changes by optical scan using 3D camera (Intellidenta AG, Basel, Switzerland). The obtained digital images of the casts reflecting the different treatment time were then superimposed and matched in one common coordinate system. The buccal surfaces of the study teeth were used as a reference point for the superimposition of different images. Subsequently, a defined area of interest at each site were measured and the difference in the linear distance between the time points were calculated.
Measured: 6 months
Secondary outcomes (3)
Gingival recession depth (GRD)
measured at the mid-buccal aspect of the study tooth from the CEJ to the most apical extension of gingival margin (using UNC-15 probe)
Measured: 6 months
Vestibular depth (VD)
measured from cemento-enamel junction (CEJ) to the deepest part of vestibular mucosa. Measurements were taken with the UNC-15 probe while exerting a firm facial pull on the lip or cheek at a 90° angle to the surface of the teeth.
Measured: 6 months
Color and texture match to the surrounding tissue
binary ratings of "equal or not equal to surrounding native tissue" assigned upon clinical examination
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 posted27 Nov 2018
- Study start5 Nov 2016
- Primary completionJul 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AugmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Prabhuji MLV, MDS, Study director, Krishnadevaraya College of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753906
- Sponsor's protocol ID
- 02_D012_71909
- Status last verified
- Feb 2019
- First submitted
- 21 Nov 2018
- Last updated
- 1 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
- ClinicalTrials.gov ID
- NCT03753906
- Acronym / sponsor ID
- 02_D012_71909
- Conditions
- Soft Tissue Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 5 Nov 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 27 Nov 2018 (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, single centre, single blind randomised controlled clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Detailed description
Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.
All the patients were implanted with self-inflating hydrogel expander (Osmed®) in subperiosteal positions using the pouch technique in the mandibular anterior region. The clinical parameters were recorded at baseline, two weeks post expander retrieval, three months and six months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.
| Arm | Type | Receives |
|---|---|---|
| Osmed® hydrogel expander implantation | Experimental | Device: Osmed® hydrogel expander implantationImplantation of Osmed® hydrogel expander was done in subperiosteal positions using the pouch technique in the mandibular anterior region. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients willing to participate in the study
- Patients above 18 years of age
- Systemically healthy patients
- Patients exhibiting keratinized tissue width < 2 mm
- Patients manifesting Miller's Class I or Class II recession
Key exclusion criteria (8 listed)
- Untreated periodontal disease, caries
- Insufficient oral hygiene
- Thin biotype ( < 0.8 mm )
- Use of tobacco
- Previous radiation therapy
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 |
|---|---|---|
| Osmed® hydrogel expander implantationUnder local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures. | Device | Osmed® hydrogel expander implantation |
Primary outcome
Keratinized tissue width (KTW)
Time frame: 6 months
measured from the most apical gingival margin to the mucogingival junction (MGJ), with the MGJ location determined using the visual method (Schiller's potassium iodide solution).
Keratinized tissue thickness (KTT)
Time frame: 6 months
measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.
Optical scanning for analysis of tissue thickness
Time frame: 6 months
alginate impressions were made at the baseline prior to expander placement, immediately after the removal of expander and 6 months post-augmentation. The prepared casts were assessed for soft tissue changes by optical scan using 3D camera (Intellidenta AG, Basel, Switzerland). The obtained digital images of the casts reflecting the different treatment time were then superimposed and matched in one common coordinate system. The buccal surfaces of the study teeth were used as a reference point for the superimposition of different images. Subsequently, a defined area of interest at each site were measured and the difference in the linear distance between the time points were calculated.
3 secondary outcomes
Gingival recession depth (GRD)
Time frame: 6 months
Vestibular depth (VD)
Time frame: 6 months
Color and texture match to the surrounding tissue
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 1 Mar 2019.
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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.
Dr. Prabhuji MLV, MDS study director
Krishnadevaraya College of Dental Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Osmed® hydrogel expander implantation in people with Soft Tissue Augmentation, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 8 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Keratinized tissue width (KTW) (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 1 Mar 2019.