Gingival Recession, LocalizedNCT04198376
The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel for Mandibular Anterior Gingival Recession Defects
A study testing Group A The Laterally Closed Tunnel Technique with SCTG and Group B Modified Coronally Advanced Tunnel Technique with SCTG. in people with Gingival Recession, Localized, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The aim of this study is to comparatively evaluate the advantages of LCT with SCTG over MCAT with SCTG for coverage of deep isolated mandibular anterior recession. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Group A The Laterally Closed Tunnel Technique with SCTG and Group B Modified Coronally Advanced Tunnel Technique with SCTG.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2020to 1 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Isolated Miller's class I, II, III or combined recession defects in mandibular arch.
- Age >/= 18 years.
- Patients with healthy or treated periodontal conditions.
- Patients willing to participate in the study.
- Absence of uncontrolled medical conditions.
- Full mouth plaque score </= 10%(O'Leary 1972).
- Full mouth bleeding score <10%(Ainamo and Bay 1975).
- Patients with esthetic concerns.
Who cannot join
- Pregnant or lactating females.
- Tobacco smoking.
- Uncontrolled medical conditions.
- Untreated periodontal conditions.
- Use of systemic antibiotics in the past 3 months.
- Patients treated with any medication known to cause gingival hyperplasia.
- Drug and alcohol abuse.
- No occlusal interferences.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karantaka, 562157
About this study
Official title: The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft for Treatment of Deep Isolated Mandibular Anterior Gingival Recession Defects: A Randomized Controlled Clinical Trial
The aim of this study is to comparatively evaluate the advantages of LCT with SCTG over MCAT with SCTG for coverage of deep isolated mandibular anterior recession.
Read the detailed description
Gingival recession is defined as the displacement of the soft tissue margin apical to the cementoenamel junction.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, high frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.
It is a common finding in patient with a high standard of oral hygiene as well as in periodontally untreated populations with poor oral hygiene.The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear.
Mandibular gingival recession defects present significant therapeutic challenges such as shallow vestibular depth, high frenal attachment, thin soft tissue biotypes leading to thin coronally advanced flaps, and thin often dehisced labial bone.Due to these factors the mandibular sites suffers strong and constant tension in comparison to the maxilla, hence there is lack of predictability in the mandibular sites.
Various surgical techniques have been proposed for the treatment of isolated mandibular recessions including the use of fully or partially epithelized free gingival grafts (FGG) or sub epithelial connective tissue graft 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).
Coronally advanced flap (CAF) +connective tissue graft (CTG) is considered as the gold standard treatment in reducing or eliminating gingival recession. Tunnel technique was first introduced by Allen in 19949, and its modifications by Zabalegui in 199910, Modified Coronally Advanced Tunnel (MCAT) by Azzi et al 2002 and Microsurgical CAT by Zuhr 2007.
However, in deep isolated mandibular recessions located in the anterior area, tension free coronal displacement of the flap can be extremely difficult and may result in decreased vestibular depth and flap dehiscence due to increased flap tension.
Therefore a new clinical approach of The Laterally Closed Tunnel (LCT), specifically designed for deep isolated anterior Mandibular Millers class I, II and III recession has been introduced to predictably cover recession and minimize the risk for post operative complications caused by unfavourable anatomical situations.
The important aspect of LCT is the wide mesiodistal and apical mobilisation of the tunnel which enables tension free lateral movement of the flap margins to cover the graft and the recession. The tension free lateral movement and the passive lateral closure of the tunnel margins maybe advantageous in the treatment of isolated deep recessions located in areas with inserting frenula or shallow vestibule, which makes a coronal tension free advancement of the flap extremely difficult.
Beside the tension free flap preparation, the use of SCTG plays a key role in increasing flap thickness and blood clot stability and in providing the cells needed for soft tissue regeneration and keratinization.
- Conditions
- Gingival Recession, Localized
- Being tested
- Group A The Laterally Closed Tunnel Technique with SCTG, Group B Modified Coronally Advanced Tunnel Technique with SCTG.
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A The Laterally Closed Tunnel Technique with SCTGProcedure or surgery
Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes.Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures.The surgical sites will be protected with a non eugenol periodontal dressing.
Group B Modified Coronally Advanced Tunnel Technique with SCTG.Procedure or surgery
In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator.A second surgical site to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingivopapillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.The surgical sites will be protected with a non eugenol periodontal dressing.
| Study group | Role | What they receive |
|---|---|---|
| The Laterally Closed Tunnel Technique with SCTG | Experimental | Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes. Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures Receives: Procedure: Group A The Laterally Closed Tunnel Technique with SCTG |
| Modified Coronally Advanced Tunnel Technique with SCTG. | Experimental | In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator .A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site. After sutures are slid through each tunnelled interdental area the needle will be pushed through the CTG before it is guided back through the undermined tissues.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingival papillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization. Receives: Procedure: Group B Modified Coronally Advanced Tunnel Technique with SCTG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Recession Depth (RD)
measured as the distance from the CEJ to the gingival margin.
Measured: 6 Months
Secondary outcomes (11)
Complete Root Coverage (CRC).
At 6 months follow up the complete root coverage for control and test group were calculated in % , each group having 12 participants each.
Measured: 6 Months
Mean Root Coverage (MRC)
The mean root coverage % achieved in control group and test group at baseline, 3 months and 6 months with each group having 12 participants each
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 (KTW)
measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction location determined using a visual method with Schiller's Potassium Iodide Solution
Measured: 6 Months
Root coverage Esthetic Score (RES)
Cairo 2009
The RES system evaluated five variables 6 months following surgery: GM, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment,and gingival color (GC)
GM.Zero points=failure of root coverage (gingival margin apical or equal to the baseline recession); 3points=partial root coverage; 6 points=CRC MTC.Zero points=irregular gingival margin (doesnot follow the CEJ); 1 point=proper marginal contour/scalloped gingival margin (follows the CEJ).
STT.Zero points=scar formation and/or keloid-like appearance; 1 point=absence of scar or keloid formation MGJ.Zero points=MGJ not aligned with the MGJ of adjacent teeth; 1 point=MGJ aligned with the MGJ of adjacent teeth.
GC.Zero points=color of tissue varies from gingival color at adjacent teeth; 1 point=normal color and integration with the adjacent soft tissues.
The ideal esthetic score was 10.
Measured: 6 Months
Gingival Recession Width
Measured as the distance between the mesial gingival margin and distal gingival margin
Measured: 6 Months
Pocket Probing Depth
Measured as the distance from the gingival margin to the base of gingival sulcus
Measured: 6 Months
Clinical Attachment Level
Measured as Gingival Recession Depth+Probing Depth
Measured: 6 Months
Plaque Index (PI)
Silness and Loe 1964
PI=0 score given when the gingival area of the tooth surface is literally free of plaque.
PI=1 represents the situation where the gingival area is covered with a thin film of plaque which is not visible,but which is made visible PI=2 score given when the deposit is visible PI=3 is reserved for the heavy (1-2mm.thick) accumulation of soft matter.
Measured: 6 Months
Gingival Index (GI)
Loe and Silness 1963
The criteria are: 0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation
Measured: 6 Months
Bleeding Index (BI)
Ainamo and Bay 1975 It is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined
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 posted13 Dec 2019
- Study start20 Jan 2020
- Primary completion31 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies 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
- The patients will be assigned into two treatment groups Group A (Test Group) comprises of patient undergoing The Laterally Closed Tunnel Technique with SCTG and Group B(Control Group) comprises of patients undergoing Modified Coronally Advanced Tunnel Technique with SCTG
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Phebie Asta Rodrigues, MDS, Principal investigator, Rajiv Gandhi University of Health SciencesDr.Joann Pauline George, MDS, Principal investigator, Rajiv Gandhi University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198376
- Sponsor's protocol ID
- 02_D012_91555
- Status last verified
- Nov 2022
- First submitted
- 12 Dec 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft for Treatment of Deep Isolated Mandibular Anterior Gingival Recession Defects: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04198376
- Acronym / sponsor ID
- 02_D012_91555
- Conditions
- Gingival Recession, Localized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 13 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 aim of this study is to comparatively evaluate the advantages of LCT with SCTG over MCAT with SCTG for coverage of deep isolated mandibular anterior recession.
Detailed description
Gingival recession is defined as the displacement of the soft tissue margin apical to the cementoenamel junction.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, high frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.
It is a common finding in patient with a high standard of oral hygiene as well as in periodontally untreated populations with poor oral hygiene.The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear.
Mandibular gingival recession defects present significant therapeutic challenges such as shallow vestibular depth, high frenal attachment, thin soft tissue biotypes leading to thin coronally advanced flaps, and thin often dehisced labial bone.Due to these factors the mandibular sites suffers strong and constant tension in comparison to the maxilla, hence there is lack of predictability in the mandibular sites.
Various surgical techniques have been proposed for the treatment of isolated mandibular recessions including the use of fully or partially epithelized free gingival grafts (FGG) or sub epithelial connective tissue graft 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).
Coronally advanced flap (CAF) +connective tissue graft (CTG) is considered as the gold standard treatment in reducing or eliminating gingival recession. Tunnel technique was first introduced by Allen in 19949, and its modifications by Zabalegui in 199910, Modified Coronally Advanced Tunnel (MCAT) by Azzi et al 2002 and Microsurgical CAT by Zuhr 2007.
However, in deep isolated mandibular recessions located in the anterior area, tension free coronal displacement of the flap can be extremely difficult and may result in decreased vestibular depth and flap dehiscence due to increased flap tension.
Therefore a new clinical approach of The Laterally Closed Tunnel (LCT), specifically designed for deep isolated anterior Mandibular Millers class I, II and III recession has been introduced to predictably cover recession and minimize the risk for post operative complications caused by unfavourable anatomical situations.
The important aspect of LCT is the wide mesiodistal and apical mobilisation of the tunnel which enables tension free lateral movement of the flap margins to cover the graft and the recession. The tension free lateral movement and the passive lateral closure of the tunnel margins maybe advantageous in the treatment of isolated deep recessions located in areas with inserting frenula or shallow vestibule, which makes a coronal tension free advancement of the flap extremely difficult.
Beside the tension free flap preparation, the use of SCTG plays a key role in increasing flap thickness and blood clot stability and in providing the cells needed for soft tissue regeneration and keratinization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be assigned into two treatment groups Group A (Test Group) comprises of patient undergoing The Laterally Closed Tunnel Technique with SCTG and Group B(Control Group) comprises of patients undergoing Modified Coronally Advanced Tunnel Technique with SCTG
| Arm | Type | Receives |
|---|---|---|
| The Laterally Closed Tunnel Technique with SCTG | Experimental | Procedure: Group A The Laterally Closed Tunnel Technique with SCTGFollowing the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes. Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures |
| Modified Coronally Advanced Tunnel Technique with SCTG. | Experimental | Procedure: Group B Modified Coronally Advanced Tunnel Technique with SCTG.In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator .A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site. After sutures are slid through each tunnelled interdental area the needle will be pushed through the CTG before it is guided back through the undermined tissues.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingival papillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Isolated Miller's class I, II, III or combined recession defects in mandibular arch.
- Age >/= 18 years.
- Patients with healthy or treated periodontal conditions.
- Patients willing to participate in the study.
- Absence of uncontrolled medical conditions.
Key exclusion criteria (8 listed)
- Pregnant or lactating females.
- Tobacco smoking.
- Uncontrolled medical conditions.
- 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 |
|---|---|---|
| Group A The Laterally Closed Tunnel Technique with SCTGFollowing the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes.Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures.The surgical sites will be protected with a non eugenol periodontal dressing. | Procedure or surgery | The Laterally Closed Tunnel Technique with SCTG |
| Group B Modified Coronally Advanced Tunnel Technique with SCTG.In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator.A second surgical site to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingivopapillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.The surgical sites will be protected with a non eugenol periodontal dressing. | Procedure or surgery | Modified Coronally Advanced Tunnel Technique with SCTG. |
Primary outcome
Gingival Recession Depth (RD)
Time frame: 6 Months
measured as the distance from the CEJ to the gingival margin.
11 secondary outcomes
Complete Root Coverage (CRC).
Time frame: 6 Months
Mean Root Coverage (MRC)
Time frame: 6 Months
Gingival Biotype Thickness
Time frame: 6 Months
Apico-coronal Width of Keratinized Tissue (KTW)
Time frame: 6 Months
Root coverage Esthetic Score (RES)
Time frame: 6 Months
Gingival Recession Width
Time frame: 6 Months
Pocket Probing Depth
Time frame: 6 Months
Clinical Attachment Level
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
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 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.Phebie Asta Rodrigues, MDS principal investigator
Rajiv Gandhi University of Health Sciences
Dr.Joann Pauline George, MDS principal investigator
Rajiv Gandhi University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A The Laterally Closed Tunnel Technique with SCTG and Group B Modified Coronally Advanced Tunnel Technique with SCTG. in people with Gingival Recession, Localized, 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 8 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 4 Nov 2022. 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 (RD) (time frame: 6 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 4 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.