Gingival Recession, LocalizedNCT03200392

Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession

A study testing laser root surface conditioning & laser DGG harvesting, laser root surface conditioning & blade DGG harvesting and blade DGG harvesting in people with Gingival Recession, Localized, run by Misr International University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective tissue graft harvesting compared to conventional scalpel surgical technique in the treatment of class I and II Miller gingival recession. Read more about this study

Who is it for?: Ages 21 to 58 yearsHealthy volunteers can take part
Conditions the study is for: Gingival Recession, Localized
What is being tested?: laser root surface conditioning & laser DGG harvesting, laser root surface conditioning & blade DGG harvesting and blade DGG harvesting
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteEgypt
Study dates: Feb 2015to Feb 2017
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 21 to 58 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Single class I, II Miller gingival recession defects (≥ 2mm in depth), presence of identifiable buccal cemento-enamel junction (CEJ) and presence of a step ≤ 1 mm at CEJ.
Controlled periodontal disease
Full-mouth plaque score of <10%; full-mouth gingival score of <15%
Patients available for 9 months follow-up period.

Who cannot join

Smokers.
Pregnant and lactating females.
Taking medications known to interfere with periodontal tissue health or healing.
Previous periodontal surgery on the involved sites.
Non-vital teeth.
Molar teeth.

Show all 9Show fewer

Recession defects associated with caries or restoration.
Occlusal interferences.
Taking anti-inflammatory drugs or antibiotics in the past 6 months.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Misr International university
Cairo, 11218

Other trials in Egypt

About this study

Official title: The Use Of Er,Cr:YSGG Laser For Recipient Bed Bio-modification And De-epithelialized Palatal Graft Harvesting In The Treatment of Gingival Recession Defects -(Randomized Clinical Trial)

Read the detailed description

Twenty four patients suffering from isolated Class I and II Miller gingival recession defects in anterior esthetic region were enrolled in this study. They were randomly assigned into three groups; de-epithelialized connective tissue graft harvesting technique or; conditioning the exposed root surfaces with Er,Cr:YSGG laser before connective tissue coverage using scalpel blade harvested de-epithelialized connective tissue graft harvesting technique, or; conditioning the exposed root surfaces with the Er,Cr:YSGG laser before Er,Cr:YSGG laser harvested connective tissue using de-epithelialized technique. Clinical and radiographic parameters were recorded at baseline and at 3, 6 and 9 months postoperatively.

Conditions: Gingival Recession, Localized
Being tested: laser root surface conditioning & laser DGG harvesting, laser root surface conditioning & blade DGG harvesting, blade DGG harvesting
Keywords: Er,Cr:YSGG laser, connective tissue graft, root coverage, mucogingival surgery, gingival recession
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 root surface conditioning & laser DGG harvestingDevice
Also called erbium, chromium:YSGG laser
laser root surface bio-modification (single application) and placement of harvested de-epithelialized gingival graft (DGG) followed by coronal repositioned flap for gingival recession Miller's I, II defect coverage
laser root surface conditioning & blade DGG harvestingDevice
Also called erbium, chromium:YSGG laser
laser root surface bio-modification (single application) and scalpel blade harvesting of de-epithelialized palatal graft (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession Miller's I, II defect coverage
blade DGG harvestingProcedure or surgery
De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage

Study groups in NCT03200392
Study group	Role	What they receive
L-DGG/LRB	Experimental	laser root surface conditioning \& laser DGG harvesting Receives: Device: laser root surface conditioning & laser DGG harvesting
B-DGG/LRB	Experimental	laser root surface conditioning \& blade DGG harvesting Receives: Device: laser root surface conditioning & blade DGG harvesting
B-DGG	Active comparator	blade DGG harvesting Receives: Procedure: blade DGG harvesting

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Recession depth
measured from the gingival margin to the cemento-enamel junction at the mid-buccal aspect of the tooth using William's graduated periodontal probe to the nearest mm
Measured: baseline-3-6-9 months

Secondary outcomes (7)

Pain assessment at the donor site
Visual Analogue Scale
Measured: 7 days
number of analgesic pills consumed per day
counting number of analgesic pills per day
Measured: 7 days
Recession width
distance between mesial and distal gingival margin of the tooth recorded on a horizontal line tangential at the CEJ to the nearest mm
Measured: baseline-3-6-9 months
Gingival thickness
determined 2mm apical to the gingival margin using standardised CBCT
Measured: baseline and at 9 months
Height of keratinized tissue width
measured form the mid-buccal aspect of the gingival margin to the mucogingival line
Measured: baseline and at 9 months
Clinical attachment loss
measured from the CEJ to the bottom of the periodontal pocket to the nearest mm.
Measured: baseline-3-6-9 months
Probing pocket depth
measured from the gingival margin to the base of the periodontal pocket to the nearest mm
Measured: baseline-3-6-9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Feb 2017

First posted27 Jun 2017
Study startFeb 2015
Primary completionJan 2017
Study completionFeb 2017

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 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03200392
Sponsor's protocol ID: 121409
Status last verified: Jul 2017
First submitted: 20 Jun 2017
Last updated: 22 Jul 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.
PubMed 26660000

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
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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
Not yet recruiting
Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized

All Gingival Recession, Localized trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use Of Er,Cr:YSGG Laser For Recipient Bed Bio-modification And De-epithelialized Palatal Graft Harvesting In The Treatment of Gingival Recession Defects -(Randomized Clinical Trial)
ClinicalTrials.gov ID: NCT03200392
Acronym / sponsor ID: 121409
Conditions: Gingival Recession, Localized
Keywords: Er,Cr:YSGG laser, connective tissue graft, root coverage, mucogingival surgery, gingival recession
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Misr International UniversityUniversity, hospital or other
Collaborators: Ain Shams University
Study start: Feb 2015 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 27 Jun 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
L-DGG/LRB	Experimental	Device: laser root surface conditioning & laser DGG harvestinglaser root surface conditioning \& laser DGG harvesting
B-DGG/LRB	Experimental	Device: laser root surface conditioning & blade DGG harvestinglaser root surface conditioning \& blade DGG harvesting
B-DGG	Active comparator	Procedure: blade DGG harvestingblade DGG harvesting

Who may qualify

Ages: 21 to 58 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Single class I, II Miller gingival recession defects (≥ 2mm in depth), presence of identifiable buccal cemento-enamel junction (CEJ) and presence of a step ≤ 1 mm at CEJ.
Controlled periodontal disease
Full-mouth plaque score of <10%; full-mouth gingival score of <15%
Patients available for 9 months follow-up period.

Key exclusion criteria (9 listed)

Smokers.
Pregnant and lactating females.
Taking medications known to interfere with periodontal tissue health or healing.
Previous periodontal surgery on the involved sites.
Non-vital teeth.

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 root surface conditioning & laser DGG harvestingAlso: erbium, chromium:YSGG laserlaser root surface bio-modification (single application) and placement of harvested de-epithelialized gingival graft (DGG) followed by coronal repositioned flap for gingival recession Miller's I, II defect coverage	Device	L-DGG/LRB
laser root surface conditioning & blade DGG harvestingAlso: erbium, chromium:YSGG laserlaser root surface bio-modification (single application) and scalpel blade harvesting of de-epithelialized palatal graft (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession Miller's I, II defect coverage	Device	B-DGG/LRB
blade DGG harvestingDe-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage	Procedure or surgery	B-DGG

Primary outcome

Change in Recession depth
Time frame: baseline-3-6-9 months
measured from the gingival margin to the cemento-enamel junction at the mid-buccal aspect of the tooth using William's graduated periodontal probe to the nearest mm

7 secondary outcomes

Pain assessment at the donor site
Time frame: 7 days
number of analgesic pills consumed per day
Time frame: 7 days
Recession width
Time frame: baseline-3-6-9 months
Gingival thickness
Time frame: baseline and at 9 months
Height of keratinized tissue width
Time frame: baseline and at 9 months
Clinical attachment loss
Time frame: baseline-3-6-9 months
Probing pocket depth
Time frame: baseline-3-6-9 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 22 Jul 2020.
Background: PubMed 26660000Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.
Individual participant dataSharing planned: No

Related trials for Gingival Recession, Localized

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
Not yet recruiting
Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized

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.

Ahmed Y Gamal, pHD study chair

Professor Department of Periodontology Ain Shams University

Tarek M Eltayeb, MSc principal investigator

Doctor student Department of Periodontology Misr International University (MIU)

Shahinaz G Elashiry, pHD study director

Associate Professor Department of Periodontology MIU

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 9 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 22 Jul 2020. 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 Egypt. 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?

Change in Recession depth (time frame: baseline-3-6-9 months). 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 NCT03200392, 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 22 Jul 2020.