Gingival RecessionPhase 4NCT02626117
Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study
A Phase 4 study testing LASER deepithelialization in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to… Read more about this study
- Who is it for?
- Ages 21 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- LASER deepithelialization
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2013to Jan 2016
- 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 21 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Pregnant and lactating woman
- Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination.
- Patients with history of smoking.
- Teeth with hopeless prognosis.
- Root surface restoration.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr Joann Pauline George
Bangalore, Karnataka, 562157
Joann pauline george, mds, 9448541637, dr.joannpaulinegeorge@gmail.com
ankita jha, bds, 09663597700, ankita_0901@yahoo.co.in
About this study
The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.
Read the detailed description
Successful treatment of recession defects to obtain new attachment and prevent repair by long junctional epithelium continues to present a serious therapeutic challenge. The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.
METHOD:
In a split-mouth study, 20 patients presenting at least one pair of bilaterally symmetrical Miller's Class I and Class II buccal gingival recessions will be selected. Control site will receive coronally advanced flap with connective tissue graft and test site will receive laser deepithelialization as an adjunct to coronally advanced flap with connective tissue graft. Gingival recession depth (GRD), Gingival recession width (GRW), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment. The root coverage outcomes were also assessed by photogrammetric analysis.
- Conditions
- Gingival Recession
- Being tested
- LASER deepithelialization, Sham LASER deepithelialization
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER deepithelializationDevice
the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..
Sham LASER deepithelializationDevice
the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. sham LASER deepithelialisation was applied to the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..
| Study group | Role | What they receive |
|---|---|---|
| CAF+ SCTG+ laser depithelialisation | Active comparator | CAF + SCTG and Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. Receives: Device: LASER deepithelialization |
| CAF+SCTG+ sham laser depithelialisation | Sham comparator | CAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium. Receives: Device: Sham LASER deepithelialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of root coverage (PRC)
Measured: 6 months
Complete root coverage
Measured: 6 months
Secondary outcomes (5)
Reductions in recession depth (Rec Red)
Measured: 6 months
Gingival recession width (GRW)
Measured: 6 months
Probing depth (PD)
Measured: 6 months
Clinical attachment level (CAL)
Measured: 6 months
Keratinized tissue width (KTW)
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 posted10 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Participant
- 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
- Joann Pauline George, MDS, Study director, krishnadevaraya college of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626117
- Sponsor's protocol ID
- 02_D012_36651
- Status last verified
- Sep 2015
- First submitted
- 1 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nevins ML, Camelo M, Schupbach P, Kim SW, Kim DM, Nevins M. Human clinical and histologic evaluation of laser-assisted new attachment procedure. Int J Periodontics Restorative Dent. 2012 Oct;32(5):497-507.
PubMed 22754897
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study
- ClinicalTrials.gov ID
- NCT02626117
- Acronym / sponsor ID
- 02_D012_36651
- 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
- Jul 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- 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 concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.
Detailed description
Successful treatment of recession defects to obtain new attachment and prevent repair by long junctional epithelium continues to present a serious therapeutic challenge. The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.
METHOD:
In a split-mouth study, 20 patients presenting at least one pair of bilaterally symmetrical Miller's Class I and Class II buccal gingival recessions will be selected. Control site will receive coronally advanced flap with connective tissue graft and test site will receive laser deepithelialization as an adjunct to coronally advanced flap with connective tissue graft. Gingival recession depth (GRD), Gingival recession width (GRW), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment. The root coverage outcomes were also assessed by photogrammetric analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+ SCTG+ laser depithelialisation | Active comparator | Device: LASER deepithelializationCAF + SCTG and Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. |
| CAF+SCTG+ sham laser depithelialisation | Sham comparator | Device: Sham LASER deepithelializationCAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium. |
Who may qualify
- Ages
- 21 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Pregnant and lactating woman
- Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination.
- Patients with history of smoking.
- Teeth with hopeless prognosis.
- Root surface restoration.
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 |
|---|---|---|
| LASER deepithelializationthe selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture.. | Device | CAF+ SCTG+ laser depithelialisation |
| Sham LASER deepithelializationthe selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. sham LASER deepithelialisation was applied to the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture.. | Device | CAF+SCTG+ sham laser depithelialisation |
Primary outcome
Percentage of root coverage (PRC)
Time frame: 6 months
Complete root coverage
Time frame: 6 months
5 secondary outcomes
Reductions in recession depth (Rec Red)
Time frame: 6 months
Gingival recession width (GRW)
Time frame: 6 months
Probing depth (PD)
Time frame: 6 months
Clinical attachment level (CAL)
Time frame: 6 months
Keratinized tissue width (KTW)
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 10 Dec 2015.
- Background: PubMed 22754897Nevins ML, Camelo M, Schupbach P, Kim SW, Kim DM, Nevins M. Human clinical and histologic evaluation of laser-assisted new attachment procedure. Int J Periodontics Restorative Dent. 2012 Oct;32(5):497-507.
- reference articleLink provided by the sponsor.
- 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.
Joann Pauline George, MDS study director
krishnadevaraya college of dental sciences
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 LASER deepithelialization 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 0 inclusion and 5 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 10 Dec 2015. 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. Some participants in this study may receive a placebo. 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 (09448541637, drjoannpaulinegeorge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of root coverage (PRC) (time frame: 6 months). The study lists 2 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 NCT02626117, which also lists 1 linked publication.
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 10 Dec 2015.