Gingival RecessionNCT06433973
Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects
A study testing Test group 1 - CM+LLLT+VISTA and Test group 2 - CM+VISTA in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root. Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Test group 1 - CM+LLLT+VISTA and Test group 2 - CM+VISTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2024to 31 Dec 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region.
- Systemically healthy individuals.
- Absence of clinical tooth mobility.
- Age >18 years old.
- A full mouth plaque index < 20%
- Patient showing adequate compliance and willing to participate in the study.
Who cannot join
- Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- patient with active periodontal disease
- smokers and tobacco users
- mal-alingned lower anteriors.
- patients who had already undergone root coverage procedure on the selected site.
- pregnant and lactating females
Show all 10Show fewer
- Involved tooth with trauma from occlusion.
- Involved tooth with prosthesis.
- Endodontically involved/ RCT treated tooth
- Tooth with cervical abrasion / undetectable CEJ/ carious.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Root Coverage Outcome by Using CM With Photobiostimulation ,CM & SCTG in Treating Isolated RT 2 Recession Defects Utilizing Minimally Invasive Technique: A RCT
Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root.
Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs).
Read more
Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement.
It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group.
Read the detailed description
Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, therefore, these were classified as Miller class III and IV or Cairo RT2 and RT3 gingival recessions (GRs). The growing emphasis on aesthetics and the desire to minimize patient discomfort have led to the advancement of various mucogingival techniques aimed at covering exposed roots. numerous techniques have been attempted to achieve root coverage of single-rooted tooth. Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity. Thus making placental allografts in dentistry a topic of growing interest and recent advancement. Other advantages like their capacity to self hydrate with blood. While these techniques have proven effective, the integration of devices capable of accelerating wound healing could enhance the outcomes of the latest graft techniques for root coverage, facilitating more predictable results.
Progress in low-level laser therapy (LLLT) within Periodontics has empowered periodontists to attain enhanced clinical outcomes. LLLT accelerates wound healing by enhancing the motility of human keratinocytes, stimulating early epithelialization, increasing fibroblast proliferation and matrix synthesis, and promoting neo vascularization.
.LLLT induces tissue surface sterilization, there by reducing the risk of bacteremia, and diminishing edema, swelling, and scarring .Additionally, it may provide greater tensile strength and stability to gingival margins, potentially preventing wound failure and reducing clinical recession. Besides all the advantages of LLLT and chorion membrane, there are very few studies which are published using theses two techniques in the recession defects. No prior research has examined the comparative efficacy of SCTG, CM + LLLT and CM for Miller's class III/RT2 recession defects. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group
- Conditions
- Gingival Recession
- Being tested
- Test group 1 - CM+LLLT+VISTA, Test group 2 - CM+VISTA, Control group - SCTG+VISTA
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group 1 - CM+LLLT+VISTAProcedure or surgery
After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec.
Test group 2 - CM+VISTAProcedure or surgery
After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures.
Control group - SCTG+VISTAProcedure or surgery
Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 - CM+LLLT+VISTA | Experimental | After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser. Receives: Procedure: Test group 1 - CM+LLLT+VISTA |
| Test group 2 - CM+VISTA | Experimental | After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Receives: Procedure: Test group 2 - CM+VISTA |
| Control group - SCTG+VISTA | Other | Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique. Receives: Procedure: Control group - SCTG+VISTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage root coverage
( Preoperative recession depth) - (Postoperative recession depth) × 100
Preoperative recession depth
Measured: 6 months
Keratinised tissue width
recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.
Measured: 6 months
interproximal Clinical attachment level (iCAL)
recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region
Measured: 6 months
Secondary outcomes (7)
Bleeding on probing (BOP)
will be recorded as 1(present) if bleeding occurs within 15 seconds of probing and 0(absent) if no bleeding occurs. It will be calculated in percentage %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by hundred. It will be designed as percentage sites with bleeding on probing
Measured: 6 months
Buccal Clinical attachment level
recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the mid-buccal region
Measured: 6 months
change in Gingival thickness
The GT will be assessed by probe transparency (TRAN) method
. Gingival thickness will be measured from the keratinized mucosa to the periosteum with a finger spreader and a silicon slider and digital calliper at a point lying in the centre of a line drawn from the gingival margin to mucogingival junction
Measured: 6 months
Recession depth
recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at the mid-labial region.
Measured: 6 months
Recession width
recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction
Measured: 6 months
Pocket probing depth
Measured in mm from the crest of the gingival margin to the base of the pocket at the mid-labial region
Measured: 6 months
Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)
The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain. Postoperative pain using visual analog scale at treated site (VAS: a scale from 0-10 ; 0 means no pain/discomfort, 10 means maximum pain /discomfort )
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 posted30 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anisha Kumari, BDS, Principal investigator, PGIDS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433973
- Sponsor's protocol ID
- Anisha Kumari Perio 24/36
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Root Coverage Outcome by Using CM With Photobiostimulation ,CM & SCTG in Treating Isolated RT 2 Recession Defects Utilizing Minimally Invasive Technique: A RCT
- ClinicalTrials.gov ID
- NCT06433973
- Acronym / sponsor ID
- Anisha Kumari Perio 24/36
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 May 2024 (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 recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root.
Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs).
Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement.
It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group.
Detailed description
Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, therefore, these were classified as Miller class III and IV or Cairo RT2 and RT3 gingival recessions (GRs). The growing emphasis on aesthetics and the desire to minimize patient discomfort have led to the advancement of various mucogingival techniques aimed at covering exposed roots. numerous techniques have been attempted to achieve root coverage of single-rooted tooth. Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity. Thus making placental allografts in dentistry a topic of growing interest and recent advancement. Other advantages like their capacity to self hydrate with blood. While these techniques have proven effective, the integration of devices capable of accelerating wound healing could enhance the outcomes of the latest graft techniques for root coverage, facilitating more predictable results.
Progress in low-level laser therapy (LLLT) within Periodontics has empowered periodontists to attain enhanced clinical outcomes. LLLT accelerates wound healing by enhancing the motility of human keratinocytes, stimulating early epithelialization, increasing fibroblast proliferation and matrix synthesis, and promoting neo vascularization.
.LLLT induces tissue surface sterilization, there by reducing the risk of bacteremia, and diminishing edema, swelling, and scarring .Additionally, it may provide greater tensile strength and stability to gingival margins, potentially preventing wound failure and reducing clinical recession. Besides all the advantages of LLLT and chorion membrane, there are very few studies which are published using theses two techniques in the recession defects. No prior research has examined the comparative efficacy of SCTG, CM + LLLT and CM for Miller's class III/RT2 recession defects. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1 - CM+LLLT+VISTA | Experimental | Procedure: Test group 1 - CM+LLLT+VISTAAfter obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser. |
| Test group 2 - CM+VISTA | Experimental | Procedure: Test group 2 - CM+VISTAAfter obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. |
| Control group - SCTG+VISTA | Other | Procedure: Control group - SCTG+VISTAScaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region.
- Systemically healthy individuals.
- Absence of clinical tooth mobility.
- Age >18 years old.
- A full mouth plaque index < 20%
Key exclusion criteria (10 listed)
- Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- patient with active periodontal disease
- smokers and tobacco users
- mal-alingned lower anteriors.
- patients who had already undergone root coverage procedure on the selected site.
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 |
|---|---|---|
| Test group 1 - CM+LLLT+VISTAAfter obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec. | Procedure or surgery | Test group 1 - CM+LLLT+VISTA |
| Test group 2 - CM+VISTAAfter obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures. | Procedure or surgery | Test group 2 - CM+VISTA |
| Control group - SCTG+VISTAScaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique. | Procedure or surgery | Control group - SCTG+VISTA |
Primary outcome
Percentage root coverage
Time frame: 6 months
( Preoperative recession depth) - (Postoperative recession depth) × 100 Preoperative recession depth
Keratinised tissue width
Time frame: 6 months
recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.
interproximal Clinical attachment level (iCAL)
Time frame: 6 months
recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region
7 secondary outcomes
Bleeding on probing (BOP)
Time frame: 6 months
Buccal Clinical attachment level
Time frame: 6 months
change in Gingival thickness
Time frame: 6 months
Recession depth
Time frame: 6 months
Recession width
Time frame: 6 months
Pocket probing depth
Time frame: 6 months
Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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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.
Anisha Kumari, BDS principal investigator
PGIDS, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test group 1 - CM+LLLT+VISTA and Test group 2 - CM+VISTA in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak 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 6 inclusion and 10 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 30 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shikha Tewari, MDS (8708249475, drshikhatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage root coverage (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 30 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.