Gingival RecessionPhase 4NCT04692558
Effect of Hyaluronic Acid on Gingival Recession Treatment
A Phase 4 study testing HYALURONIC ACID and coronally advanved flap with connective tissue harvesting in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Gingival marginal tissue recession is the displacement of the soft tissue margin apical to the cementoenamel junction (CEJ) with exposure of the root surface. It is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- HYALURONIC ACID and coronally advanved flap with connective tissue harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 2 Jan 2020to 30 Oct 2021
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients willing to participate in the study.
- Age ≥ 18 to 55 years of age.
- Patients with healthy or treated periodontal condition.
- Full-mouth plaque score (FMPS) < 15%.
- Presence of at least one buccal recession (depth ≥ 2 mm) with no loss of interproximal attachment classified as Miller class I,II RT/1 in the anterior maxillary or mandibular area (central and lateral incisors, canine, and first and second premolars).
- Associated with esthetic problems and/or dental hypersensitivity.
- Gingival recession with at least 1 mm of keratinized tissue (KT) apical to the recession and thick gingival biotype (>0.8mm gingival thickness)
Who cannot join
- Active periodontal disease at sites (probing pocket depth < 4 mm and no bleeding on probing).
- Pregnant or lactating females.
- Tobacco smoking.
- Uncontrolled medical conditions.
- Untreated periodontal conditions.
- Use of systemic antibiotics in the past 3 months.
Show all 11Show fewer
- Patients treated with any medication known to cause gingival hyperplasia.
- Drug and alcohol abuse.
- Occlusal interferences.
- History of mucogingival or periodontal surgery at the experimental site.
- Patients with a known hypersensitivity or allergy to hyaluronic acid.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Krishnadevaray College of Dental Science and Hospital
Bangalore, Karnataka, 562157
SUSAN S, MDS, 7619297823 ext. +91, suziejazz.23@gmail.com
About this study
Official title: Efficacy of Hyaluronic Acid on Connective Tissue Graft With Coronally Advanced Flap in the Treatment of Isolated Gingival Recession - A Randomized Controlled Clinical Trial.
Gingival marginal tissue recession is the displacement of the soft tissue margin apical to the cementoenamel junction (CEJ) with exposure of the root surface. It is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots leading to esthetic concerns and dentinal hypersensitivity are the most frequent reasons for patients to seek treatment for the same.
Gingival recession therapy is still challenging for clinicians. The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an esthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths.
Read more
Various treatment modalities have been put forth for the correction of gingival recession. These include free gingival autograft, subepithelial connective tissue graft (SCTG), coronally advanced flap (CAF) and various combinations. Coronally advanced flap (CAF) in conjunction with the connective tissue graft (CTG) is considered the gold standard of treatment of gingival recession due to its high predictability of the treatment results.
Several authors have explored the use of biological agents or like enamel matrix derivative (EMD), platelet-derived growth factor-BB (PDGF), fibroblast growth factor-2 (FGF-2), which are a group of proteins capable of inducing gene or cell activation for cell recruitment, matrix biosynthesis, and cellular differentiation, in an attempt to regenerate the lost periodontium to enhance its long term stability Hyaluronic acid (HA) is one such biologic agent that demonstrates future for periodontal regeneration. It is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to allow the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues. HA suppresses tissue breakdown activating metalloproteinase inhibitors. It represents one of the most hygroscopic molecules known in nature. As a physical background material, it functions as space filler, lubricant and a protein excluder as well. In vitro studies and animal studies have demonstrated that HA significantly increases the tensile strength of granulation tissue, stimulates clot formation, induces angiogenesis, increases osteogenesis, and does not interfere in the calcification nodules during bone formation. Furthermore, HA facilitates cell migration and differentiation during tissue formation and repair of both soft and hard tissues. It improves ligament cell viability and early osteogenic differentiation.
Considering the fact that HA has positive effects on wound healing, we hypothesized that it may also improve the results of root coverage by CAF+CTG. Therefore, the aim of this randomized controlled clinical trial (RCT) will be to evaluate the potential benefit of the adjunctive use of HA in combination with CAF+CTG and to compare the outcomes with CAF+CTG alone, when treating single Miller class I and class II/RT1gingival recessions.
Read the detailed description
- After administration of local anesthesia
- Two oblique and divergent releasing incisions extending beyond the mucogingival junction (MGJ) will be performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth
- A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique as described by Hurzeler and Weng.
- For the control group, only CAF+CTG will be performed. For the test group, cross-linked HA will be applied over the exposed root surface before the placement of CTG and CAF closure. HA will be presented as individual cartridge for single use only. For the application on the denuded root surface, the cartridge will be inserted into a cartridge syringe with 23G needles, as the fabricant recommended. HA will be applied on the root surface until completely covered, the harvested CTG will be placed and stabilized with sutures . Finally, the flap will be coronally displaced and sutured covering the CEJ. Interrupted sutures will be placed at the vertical releasing incisions in apical-coronal direction to reduce the tension and to facilitate the coronal displacement to perform the last coronal sling suture.
- Post-operative pain and edema will be controlled with anti-inflammatory drugs. Patients received Ibuprofen 400 mg thrice daily for 3 days19 and Amoxicillin 500mg thrice daily for 5 days.28 For patients allergic to penicillin Clindamycin 300 mg 4 times daily for 5 days will be prescribed.29
- A 60s rinse with 0.2% chlorhexidine gluconate was prescribed two times per day for the first 2 weeks.
- All participants will be instructed to intermittently apply an ice bag on the operated area.
- Participants will be recalled after a period of 14 days for suture removal. After this period patients will be reinstructed in mechanical cleaning of the treated teeth and use of a soft toothbrush and roll technique of brushing for one month.3
- Participants will be recalled for reinforcement of oral hygiene instructions and light debridement supragingivally will be carried out. Clinical parameters will be recorded at 6 weeks, 3 months and 6 months after surgical procedure.18
- Conditions
- Gingival Recession
- Being tested
- HYALURONIC ACID, coronally advanved flap with connective tissue harvesting
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYALURONIC ACIDBiological
Also called HA
Hyaluronic acid will be applied on denuded root surface after reflection of isolated gingival recession.
coronally advanved flap with connective tissue harvestingProcedure or surgery
Also called CAF+CTG
Coronally advanced flap surgery with connective tissue harvesting from palate
| Study group | Role | What they receive |
|---|---|---|
| HYALURONIC ACID | Experimental | CAF+CTG+HA Receives: Biological: HYALURONIC ACID; Procedure: coronally advanved flap with connective tissue harvesting |
| WITHOUT HYALURONIC ACID | Active comparator | CAF+CTG Receives: Procedure: coronally advanved flap with connective tissue harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in recession depth (RD)
- measured as the distance from CEJ to the gingival margin.
Measured: 6 MOonths
complete root coverage (CRC)
PERCENTAGE OF 100% ROOT COVERAGE
Measured: 6 Months
mean root coverage (MRC)
MEASUREMENT OF AMOUNT OF COVERAGE OBTAINED OVER ALL
Measured: 6 Months
• Gingival recession width (GRW)
measured as the distance between the mesial gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction)
Measured: 6 Months
gingival thickness
In the direct method, the tissue thickness is measured using a periodontal probe.
Measured: 6 Months
root coverage esthetic scores (RES).
Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. ... This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.
Measured: 6 Months
Secondary outcomes (8)
Pocket probing depth
Measure the pocket depth of the groove between your gums and teeth by placing a dental probe beside your tooth beneath your gumline, usually at several sites throughout your mouth. In a healthy mouth, the pocket depth is usually between 1 and 3 millimeters (mm). Pockets deeper than 4 mm may indicate periodontitis.
Measured: 6 Months
clinical attachment level (CAL)
CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket. When the gingival margin is coronal to the CEJ, you subtract (from the probing depth) the distance from the CEJ to the gingival margin.
Measured: 6 Months
width of keratinized tissue (KTW)
Place your probe on the outside of the tissue and measure from the gingival margin to the mucogingival junction. Now measure the sulcus or pocket depth (probing depth). Subtract the probing depth from the outside measurement of the gingiva, and you will have the width of attached gingiva.
Measured: 6 Months
plaque index (PI)
Plaque Index = (2+1+1+2) / 4 = 1.5, according to the plaque index system this means the plaque index for the tooth is moderate accumulation of soft deposit within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
Measured: 6 Months
gingival index (GI)
The Gingival Index (Löe and Silness, 1963) was created for the assessment of the gingival condition and records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately on the basis of 0 to 3.
Measured: 6 Months
bleeding index (BI)
The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable way for assessing a patient's progress in Plaque control. The presence or absence of gingival bleeding is determined by gentle probing of the gingival crevice with a periodontal probe. The appearance of bleeding within 10 seconds indicates a positive score, which is expressed as percentage of the total number of gingival margin examined.
Measured: 6 Months
VAS scale for pain and esthetic
Esthetics-post treatment outcomes. 0-Not Satisfied 10- Very Satisfied
Measured: 14 days
The Wound healing index
Wound Healing Index (Huang et al 2005) Score 1 Uneventful healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence.
Score 2 Uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration.
Score 3 Poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start2 Jan 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PRABHUJI MLV, MDS, Study director, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692558
- Sponsor's protocol ID
- 02_D012_102617
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.
PubMed 29961138Kumar R, Srinivas M, Pai J, Suragimath G, Prasad K, Polepalle T. Efficacy of hyaluronic acid (hyaluronan) in root coverage procedures as an adjunct to coronally advanced flap in Millers Class I recession: A clinical study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):746-50. doi: 10.4103/0972-124X.147411.
PubMed 25624632
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid on Connective Tissue Graft With Coronally Advanced Flap in the Treatment of Isolated Gingival Recession - A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04692558
- Acronym / sponsor ID
- 02_D012_102617
- Conditions
- Gingival Recession
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 5 Jan 2021 (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.
Gingival marginal tissue recession is the displacement of the soft tissue margin apical to the cementoenamel junction (CEJ) with exposure of the root surface. It is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots leading to esthetic concerns and dentinal hypersensitivity are the most frequent reasons for patients to seek treatment for the same.
Gingival recession therapy is still challenging for clinicians. The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an esthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths.
Various treatment modalities have been put forth for the correction of gingival recession. These include free gingival autograft, subepithelial connective tissue graft (SCTG), coronally advanced flap (CAF) and various combinations. Coronally advanced flap (CAF) in conjunction with the connective tissue graft (CTG) is considered the gold standard of treatment of gingival recession due to its high predictability of the treatment results.
Several authors have explored the use of biological agents or like enamel matrix derivative (EMD), platelet-derived growth factor-BB (PDGF), fibroblast growth factor-2 (FGF-2), which are a group of proteins capable of inducing gene or cell activation for cell recruitment, matrix biosynthesis, and cellular differentiation, in an attempt to regenerate the lost periodontium to enhance its long term stability Hyaluronic acid (HA) is one such biologic agent that demonstrates future for periodontal regeneration. It is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to allow the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues. HA suppresses tissue breakdown activating metalloproteinase inhibitors. It represents one of the most hygroscopic molecules known in nature. As a physical background material, it functions as space filler, lubricant and a protein excluder as well. In vitro studies and animal studies have demonstrated that HA significantly increases the tensile strength of granulation tissue, stimulates clot formation, induces angiogenesis, increases osteogenesis, and does not interfere in the calcification nodules during bone formation. Furthermore, HA facilitates cell migration and differentiation during tissue formation and repair of both soft and hard tissues. It improves ligament cell viability and early osteogenic differentiation.
Considering the fact that HA has positive effects on wound healing, we hypothesized that it may also improve the results of root coverage by CAF+CTG. Therefore, the aim of this randomized controlled clinical trial (RCT) will be to evaluate the potential benefit of the adjunctive use of HA in combination with CAF+CTG and to compare the outcomes with CAF+CTG alone, when treating single Miller class I and class II/RT1gingival recessions.
Detailed description
- After administration of local anesthesia
- Two oblique and divergent releasing incisions extending beyond the mucogingival junction (MGJ) will be performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth
- A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique as described by Hurzeler and Weng.
- For the control group, only CAF+CTG will be performed. For the test group, cross-linked HA will be applied over the exposed root surface before the placement of CTG and CAF closure. HA will be presented as individual cartridge for single use only. For the application on the denuded root surface, the cartridge will be inserted into a cartridge syringe with 23G needles, as the fabricant recommended. HA will be applied on the root surface until completely covered, the harvested CTG will be placed and stabilized with sutures . Finally, the flap will be coronally displaced and sutured covering the CEJ. Interrupted sutures will be placed at the vertical releasing incisions in apical-coronal direction to reduce the tension and to facilitate the coronal displacement to perform the last coronal sling suture.
- Post-operative pain and edema will be controlled with anti-inflammatory drugs. Patients received Ibuprofen 400 mg thrice daily for 3 days19 and Amoxicillin 500mg thrice daily for 5 days.28 For patients allergic to penicillin Clindamycin 300 mg 4 times daily for 5 days will be prescribed.29
- A 60s rinse with 0.2% chlorhexidine gluconate was prescribed two times per day for the first 2 weeks.
- All participants will be instructed to intermittently apply an ice bag on the operated area.
- Participants will be recalled after a period of 14 days for suture removal. After this period patients will be reinstructed in mechanical cleaning of the treated teeth and use of a soft toothbrush and roll technique of brushing for one month.3
- Participants will be recalled for reinforcement of oral hygiene instructions and light debridement supragingivally will be carried out. Clinical parameters will be recorded at 6 weeks, 3 months and 6 months after surgical procedure.18
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYALURONIC ACID | Experimental | Biological: HYALURONIC ACID, Procedure: coronally advanved flap with connective tissue harvestingCAF+CTG+HA |
| WITHOUT HYALURONIC ACID | Active comparator | Procedure: coronally advanved flap with connective tissue harvestingCAF+CTG |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients willing to participate in the study.
- Age ≥ 18 to 55 years of age.
- Patients with healthy or treated periodontal condition.
- Full-mouth plaque score (FMPS) < 15%.
- Presence of at least one buccal recession (depth ≥ 2 mm) with no loss of interproximal attachment classified as Miller class I,II RT/1 in the anterior maxillary or mandibular area (central and lateral incisors, canine, and first and second premolars).
Key exclusion criteria (11 listed)
- Active periodontal disease at sites (probing pocket depth < 4 mm and no bleeding on probing).
- Pregnant or lactating females.
- Tobacco smoking.
- Uncontrolled medical conditions.
- Untreated periodontal conditions.
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 |
|---|---|---|
| HYALURONIC ACIDAlso: HAHyaluronic acid will be applied on denuded root surface after reflection of isolated gingival recession. | Biological | HYALURONIC ACID |
| coronally advanved flap with connective tissue harvestingAlso: CAF+CTGCoronally advanced flap surgery with connective tissue harvesting from palate | Procedure or surgery | HYALURONIC ACID, WITHOUT HYALURONIC ACID |
Primary outcome
The difference in recession depth (RD)
Time frame: 6 MOonths
- measured as the distance from CEJ to the gingival margin.
complete root coverage (CRC)
Time frame: 6 Months
PERCENTAGE OF 100% ROOT COVERAGE
mean root coverage (MRC)
Time frame: 6 Months
MEASUREMENT OF AMOUNT OF COVERAGE OBTAINED OVER ALL
• Gingival recession width (GRW)
Time frame: 6 Months
measured as the distance between the mesial gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction)
gingival thickness
Time frame: 6 Months
In the direct method, the tissue thickness is measured using a periodontal probe.
root coverage esthetic scores (RES).
Time frame: 6 Months
Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. ... This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.
8 secondary outcomes
Pocket probing depth
Time frame: 6 Months
clinical attachment level (CAL)
Time frame: 6 Months
width of keratinized tissue (KTW)
Time frame: 6 Months
plaque index (PI)
Time frame: 6 Months
gingival index (GI)
Time frame: 6 Months
bleeding index (BI)
Time frame: 6 Months
VAS scale for pain and esthetic
Time frame: 14 days
The Wound healing index
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 29961138Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.
- Background: PubMed 25624632Kumar R, Srinivas M, Pai J, Suragimath G, Prasad K, Polepalle T. Efficacy of hyaluronic acid (hyaluronan) in root coverage procedures as an adjunct to coronally advanced flap in Millers Class I recession: A clinical study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):746-50. doi: 10.4103/0972-124X.147411.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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, MDS study director
Krishnadevaraya College of Dental Sciences & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HYALURONIC ACID and coronally advanved flap with connective tissue harvesting 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 11 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 5 Jan 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 JOANN PAULINE GEORGE, MDS (9448541637 ext. +91, drpaulinegeorge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in recession depth (RD) (time frame: 6 MOonths). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04692558, which also lists 2 linked publications.
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 5 Jan 2021.