An Open Prospective Randomized Controlled Clinical Trial to Examine the Efficacy of Methods to Treat Multiple Gingival Recession Defects

Efficacy of Methods to Treat Multiple Gingival Recession Defects



Sponsors


Source

University of Southern California

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

No


Brief Summary

Rationale: Treatment of gingival recession defects requires coronal advancement of the
gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth
prognosis, which can be accomplished either through a flap procedure or through a tunnel. It
will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel
Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.

Another aspect of the study is to determine whether autologous concentrate of platelets and
leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective
tissue autologous graft harvested from the palate.

The overall objective of this study is to evaluate the effectiveness of therapeutic
modalities for the treatment of multiple gingival recession defects.

The study is designed as a prospective, randomized controlled clinical trial. Four groups
will be compared:

Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST)
Group 4: VISTA + L-PRF

Each of the groups will be treated without any graft material in order to examine the
efficacy of coronal advancement and periodontal root coverage without the confounding
variable of graft material. These techniques don't require any additional graft if there is
adequate amount of keratinized gingiva

The study population will be patients who present to Advanced Graduate Program in
Periodontology at the University of Southern California, USA, and are deemed to require
treatment of multiple gingival recession defects. A total sample of 100 participants (23
participants per group) will provide a two sided test of means with 80% power at alpha of
0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC.
Kaysville, Utah.)

The study duration will be 1 year. Follow-up visits after the surgery will occur after 3
days , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with
standard of care follow up for gingival recession treatment and there will be no additional
costs to the participant.

The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are
clinical attachment level (CAL) gain, changes in gingival thickness and volume and the
Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey

Overall Status

Not yet recruiting

Start Date

2017-06-01

Completion Date

2020-06-01

Primary Completion Date

2019-06-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Complete root coverage
12 months

Secondary Outcome

Measure

Time Frame

Clinical Attachment Level gain
12 months
% root coverage
12 months
Gingival Thickness Gain
12 months
Gingival Volume Gain
12 months

Enrollment

100

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

Coronally advanced flap will be performed. Briefly, sulcular incisions will be made. Oblique incisions will be made on each papilla requiring root coverage. In the region coronal to the mucogingival junction (MGJ), mucoperiosteal flap will be elevated. Apical to the MGJ, sharp dissection will be performed to the periosteum allowing split-thickness flap elevation to be performed. Epithelium is removed from the papillae adjacent to the recession and the flap is coronally positioned and stabilized with interproximal sutures and apico-coronal interrupted sutures to close the vertical releasing incisions.

Arm Group Label

Coronally Advanced Flap


Intervention Type

Procedure

Intervention Name


Description

Initial sulcular incisions are made and small, contoured blades and mini curettes are used to create the recipient pouches and tunnels. The tunnel will be subperiosteal in location. The incision is extended to one adjacent tooth both mesially and distally. This incision maintains the full height and thickness of the gingival component and enables access beneath the buccal gingiva. The connective tissue beyond the mucogingival line will be dissected and free the buccal flap from its insertions to the bone around each tooth. Muscle fibers and any remaining collagen fibers on the inner aspect of the flap, which prevent the buccal gingiva from being moved coronally, are cut. The papillae are kept intact and undermined to maintain their integrity and carefully released from the underlying bone, which allows the coronal positioning of the papillae. An envelope, full-thickness pouch, and tunnel are created and extended apically beyond the mucogingival line by blunt dissection

Arm Group Label

Intrasulcular tunneling


Intervention Type

Biological

Intervention Name


Description

The VISTA approach begins with a Vestibular Incision Subperiosteal Tunnel Access. Through this incision a subperiosteal tunnel is created, exposing the facial osseous plate and root dehiscence. This tunnel will be extended at least one or two teeth beyond the teeth requiring root coverage to mobilize gingival margins and facilitate coronal repositioning. Additionally, the subperiosteal tunnel is extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla. The mucogingival complex is then advanced coronally and stabilized in the new position with the coronally anchored suturing technique, which entails placing a horizontal mattress suture apical to the gingival margin of each tooth. The suture is tied to position the knot at the midcoronal point of the facial aspect of each tooth, which is secured with help of composite resin to prevent apical relapse of the gingival margin during initial stages of healing.

Arm Group Label

Vestibular Incision Subperiosteal Tunnel Access (VISTA)

VISTA + Leukocyte-Platelet Rich Fibrin



Intervention Type

Biological

Intervention Name


Description

Immediately prior to surgery, 72 mL of blood should be drawn from each patient by venipuncture of the antecubital vein and collected in a sterile glass test tube without any anticoagulant. Tubes should be centrifuged at 2,700 rpm for 12 minutes within 2 minutes after blood draw. For individuals on anti-coagulant therapy or supplements to interfere with coagulation, centrifugation will be for 18 minute. After centrifugation, each L-PRF clot will be separated from the portion of red blood cells (red thrombus), obtaining a fibrin clot with a red small portion in order to include the "buffy" coat richer in leucocytes. The L-PRF clot is condensed and modeled on a sterile surgical plate. L-PRF will be used within 60 minutes after the preparation.

Arm Group Label

VISTA + Leukocyte-Platelet Rich Fibrin



Eligibility

Criteria

Inclusion Criteria:

- Male and female individuals between ages of 18 to 70 years old

- Multiple contiguous gingival recession defects on a minimum of two adjacent teeth,
exhibiting 3mm or more recession on at least one of those teeth

- No prior surgical treatment in the sites planned for therapy

- Minimum of 2 mm of keratinized gingiva

- Absence of cervical restorations extending to the CEJ

- Miller class 1, 2 and 3 recession defects will be included

- Availability to undergo treatment and return for follow up visits at specified
post-operative intervals

Exclusion Criteria:

- Molar teeth

- Milller Class 4 recession defects

- Pregnancy (Self-reported)

- Smoking

- Uncontrolled local or systemic diseases that affects wound healing (diabetes,
autoimmune or inflammatory disorders)

- Past history of systemic steroid use over 2 weeks within the last 2 years

- Poor oral hygiene on a non-compliant individual

- Ibuprofen Allergy/interlerance

- Anticoagulant therapy (e.g. Warfarin, Plavix, etc.), will not be automatic exclusion
but patients will be required to have INR test performed and have values between 2.0
to 3. Physician consultation will be requested to determine whether anticoagulant
therapy can be discontinued for 3 days prior to surgery.

- Objection to blood draw or application of blood products

- Students and staff from USC Ostrow school of Dentistry will not be recruited for this
study

Gender

All

Minimum Age

18 Years

Maximum Age

70 Years

Healthy Volunteers

No


Overall Contact

Last Name

Homa Zadeh, DDS, PhD

Phone

8186324662

Email

[email protected]


Verification Date

2017-04-01

Lastchanged Date

2017-04-18

Firstreceived Date

2017-04-18

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Southern California

Investigator Full Name

Homa Zadeh

Investigator Title

Associate Professor and Director, Department of Advanced Periodontology


Has Expanded Access

No

Condition Browse


Number Of Arms

4

Arm Group

Arm Group Label

Coronally Advanced Flap

Arm Group Type

Experimental


Arm Group Label

Vestibular Incision Subperiosteal Tunnel Access (VISTA)

Arm Group Type

Experimental


Arm Group Label

Intrasulcular tunneling

Arm Group Type

Experimental


Arm Group Label

VISTA + Leukocyte-Platelet Rich Fibrin

Arm Group Type

Experimental



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Neema Bakhshalian, DDS, MS, PhD

Phone

2133628076

Email

[email protected]


Other Outcome

Measure

Patient-reported outcomes

Time Frame

3 days

Description

Includes: pain experienced within the mouth as a whole, pain experienced while drinking beverages, pain experienced while chewing, pain experienced in the morning, Pain experienced throughout the day, Pain experienced at night, Edema experienced after the surgery all measure with the use of a Visual Analogue Scale


Measure

objective esthetic assessment

Time Frame

6 months

Description

This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage is the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage is 60% of the total score, whereas 40% is assigned to the other four variables.



Patient Data

Sharing Ipd

Yes

Ipd Description

The intra-oral clinical photography, CBCT scans, study models and clinical data will be shared with other investigators for data analysis.


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Outcomes Assessor



ClinicalTrials.gov processed this data on April 21, 2017

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Interventions

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In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

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In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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