Free Mucogingival Graft for Isolated Root Coverage
Primary Purpose
Free Mucogingival Grafts, Gingival Recession, Root Coverage
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Buccal muco-gingival tissue graft
Palatal connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Free Mucogingival Grafts
Eligibility Criteria
Inclusion Criteria: Healthy patients with deep GR associated with lower incisor MCD. Full mouth plaque and bleeding scores were <20%. Exclusion Criteria: Patient characteristics: Smoking ≥10 cigarettes a day. Medications or systemic contraindications for oral surgery. Pregnancy. Defects: Thin scalloped biotype (AND/OR) Underlying bone dehiscence (AND /OR) Generalized GR affecting most sextants.
Sites / Locations
- Centro Odontologico Del Sureste SlpRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buccal muco-gingival tissue graft
Palatal connective tissue graft
Arm Description
Outcomes
Primary Outcome Measures
buccal Recession (bREC)
Buccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Secondary Outcome Measures
buccal Clinical Attachment Level (bCAL)
bCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the buccal aspect.
interproximal Clinical Attachment Level (iCAL)
iCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the interproximal aspect.
Interproximal papilla tip location (PT)
Taking as reference the level of the mid-axis of the tooth, PT will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise.
This outcome will be assessed with a periodontal probe and measured in mmm.
keratinized tissue width (KT)
KT will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
vestibule depth (VD)
VD will be measured, from the mucosal margin to the point of greatest concavity of the mucobuccal fold. The measure will be assessed with a periodontal probe in mm.
Soft tissue attached to alveolar bone (STAB)
STAB will be measured from the gingival margen to the perpendicular mucosal insertion. The measure will be assessed with a periodontal probe in mm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05851248
Brief Title
Free Mucogingival Graft for Isolated Root Coverage
Official Title
Free Mucogingival Graft for Isolated Root Coverage and Correct Unfavorable Mucogingival Conditions in Lower Incisors: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Free Mucogingival Grafts, Gingival Recession, Root Coverage, Periodontal Plastic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buccal muco-gingival tissue graft
Arm Type
Experimental
Arm Title
Palatal connective tissue graft
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Buccal muco-gingival tissue graft
Intervention Description
Recipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes.
Donor site preparation. The incisions will be made in the same way as in the recipient area, including both papillae. The vertical incision will measure the distance from the cementoenamel junction (CEJ) to the bony dehiscence in the GR tooth, plus at least 2 mm. The tissue between the incisions will be elevated fjull or partial thickness close to the bone in the keratinized portion and superficially in the mucosal portion. A soft tissue substitute will be adapted and sutured to protect the donor site.
Intervention Type
Procedure
Intervention Name(s)
Palatal connective tissue graft
Intervention Description
Recipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes.
Donor site preparation A connective tissue graft will be taken from the palatal area, at the level of the premolars, which will include the two papillae. The size of the graft will be the same as that of the recipient area. A soft tissue substitute will be adapted and sutured to protect the donor site, especially if there is exposed bone.
Primary Outcome Measure Information:
Title
buccal Recession (bREC)
Description
Buccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
buccal Clinical Attachment Level (bCAL)
Description
bCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the buccal aspect.
Time Frame
12 months
Title
interproximal Clinical Attachment Level (iCAL)
Description
iCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the interproximal aspect.
Time Frame
12 months
Title
Interproximal papilla tip location (PT)
Description
Taking as reference the level of the mid-axis of the tooth, PT will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise.
This outcome will be assessed with a periodontal probe and measured in mmm.
Time Frame
12 months
Title
keratinized tissue width (KT)
Description
KT will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Time Frame
12 months
Title
vestibule depth (VD)
Description
VD will be measured, from the mucosal margin to the point of greatest concavity of the mucobuccal fold. The measure will be assessed with a periodontal probe in mm.
Time Frame
12 months
Title
Soft tissue attached to alveolar bone (STAB)
Description
STAB will be measured from the gingival margen to the perpendicular mucosal insertion. The measure will be assessed with a periodontal probe in mm.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Root Coverage (RC percentage)
Description
RC percentage will be calculated by the following formula: [(basaline recession depth - 12 months recession depth) / basaline recession depth] x100. The measure will be assessed with a periodontal probe in mm.
Time Frame
12 months
Title
Complete root coverage (CRC)
Description
It will assessed if the gingival margen is at or above the CEJ. The measure will be assessed with a periodontal probe in mm.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy patients with deep GR associated with lower incisor MCD.
Full mouth plaque and bleeding scores were <20%.
Exclusion Criteria:
Patient characteristics:
Smoking ≥10 cigarettes a day.
Medications or systemic contraindications for oral surgery.
Pregnancy.
Defects:
Thin scalloped biotype (AND/OR)
Underlying bone dehiscence (AND /OR)
Generalized GR affecting most sextants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name or Official Title & Degree
José A Moreno-Rodríguez, DDS
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
Facility Information:
Facility Name
Centro Odontologico Del Sureste Slp
City
Murcia
ZIP/Postal Code
30007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name & Degree
Jose A Moreno-Rodriguez
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
12. IPD Sharing Statement
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Free Mucogingival Graft for Isolated Root Coverage
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