Timing Suture Removal on Root Coverage Procedures
Primary Purpose
Gingival Recession, Suture, Root Coverage
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Suture removal
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- ≥18 years
- periodontally and systemically healthy
- presence of at least two consecutive Cairo type I (RT1) gingival recession defects
- recession >2mm in depth at the buccal aspect
- full-mouth plaque and bleeding score ≤20%
- no previous periodontal surgery; presence of identifiable cemento-enamel junction (CEJ) (a step 1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).
Exclusion Criteria:
- smokers >10 cigarettes a day
- contraindications for periodontal surgery
- medications known to affect the gingiva or interfere with wound healing
- pregnancy and lactating females
- active orthodontic therapy
- caries or restorations in the area to be treated.
- Patients unable to follow post-surgical medication instructions adequately.
Sites / Locations
- International University of CatalunyaRecruiting
- International University of CatalunyaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Timing suture removal_1 week
Timing suture removal_2 weeks
Timing suture removal_3 weeks
Arm Description
Outcomes
Primary Outcome Measures
Mean Root Coverage (MRC) in percentage (%)
the average improvement in millimeters of the recession depth will be calculated as a percentage
Secondary Outcome Measures
Complete root coverage (CRC)
Change in Keratinized Tissue Width (KT) at 3- and 6-months post-surgery.
Change in gingival thickness (GT) at 3- and 6-months post-surgery
Pain and discomfort of the suture of the grafted area.
Full Information
NCT ID
NCT04826653
First Posted
March 29, 2021
Last Updated
November 1, 2022
Sponsor
Universitat Internacional de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT04826653
Brief Title
Timing Suture Removal on Root Coverage Procedures
Official Title
Influence of Timing Suture Removal on Root Coverage Procedures: a Randomized Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gingival recession is defined as the displacement of the soft tissue margin apical to the cemento-enamel junction with exposure of the root surface. It affects a broad population with presence of periodontal disease as well as periodontally healthy individuals. The occurrence of gingival recessions is age-dependent and their development begins relatively early in life. For instance, gingival recessions were noticed in more than 60% of Norwegian 20-year-olds and in more than 90% of the older population. Similar findings were reported in Brazilian and French population. In populations deprived of dental care, the occurrence of gingival recessions was even higher.
Many factors have been implicated in the etiology of gingival recession, including plaque, position of the tooth in the arch and improper toothbrushing. It is difficult to see a single cause for the development of labial gingival recession.
It has been demonstrated in several investigations that if left untreated, the probability of progression of the recession is high even with good oral hygiene. The indications for treatment of gingival recession are: esthetics, dental hypersensitivity, and the prevention of caries as well as further progression of the recession. Therapeutic options for recessions have been well documented with a high degree of success. Their ultimate goal is the location of the gingival margin coronal to the CEJ, with minimal probing depth and a pleasant soft tissue integration with the adjacent teeth.
With such a prevalent condition, it becomes critical to discriminate when to treat these lesions and which are the anatomical and surgical characteristics that are going to determine the amount of root coverage.
Regarding surgical characteristics, it has been demonstrated that the accomplishment of complete root coverage may be prejudiced by the post-surgical position of the gingival margin (the more coronal to the CEJ the greater the chance to achieve root coverage). The same author conducted a randomized clinical trial showing that the higher the flap tension, the lower the recession reduction. Another surgical factor affecting root coverage may be the use of microsurgical approaches by the use of smaller diameter sutures. According to a recently published systematic review, early suture removal (less than 10 days) can negatively affect root coverage outcome.
The healing process after pedicle graft was investigated in an animal model study. The healing was divided into four different stages, the adaption stage (0-4 days), the proliferation stage (4-21 days), the attachment stage (27-28 days) and the maturation stage (1-6 months). During the proliferation stage, connective tissue invades the fibrin layer from the basal level of the flap, and after 6-10 days a layer of fibroblasts is seen in apposition to the root surface. These cells are believed to differentiate into cementoblasts at a later stage of healing. At the end of the proliferation stage, thin collagen fibers are formed adjacent to the root surface, but a fibrous union between the connective tissue and the root has not been observed. It seems logical that stabilizing the flap with sutures for a prolonged period of time during the proliferation phase would help maintain the gingival margin on a more coronal position postoperatively. On the other hand, the longer the sutures remain postoperatively, the greater the chances of plaque accumulation and inflammation affecting negatively to root coverage.
The systematic review by Tatakis and Chambrone included 17 randomized clinical trials that provided an overall data of 325 single recession defects that were treated by coronally advanced flap. While they investigated time of suture removal, the studies included in this study did not account for this variable, thus leading to some bias. Moreover, different suture materials, type of suturing technique may also play an important role in the healing process. Therefore, the aim of this study is to evaluate the clinical outcome of timing suture removal regarding root coverage on coronally advanced flap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Suture, Root Coverage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Timing suture removal_1 week
Arm Type
Experimental
Arm Title
Timing suture removal_2 weeks
Arm Type
Experimental
Arm Title
Timing suture removal_3 weeks
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Suture removal
Intervention Description
Suture removal after coronally advanced flap plus a connective tissue graft
Primary Outcome Measure Information:
Title
Mean Root Coverage (MRC) in percentage (%)
Description
the average improvement in millimeters of the recession depth will be calculated as a percentage
Time Frame
3- and 6-months post-surgery
Secondary Outcome Measure Information:
Title
Complete root coverage (CRC)
Time Frame
3- and 6-months post-surgery
Title
Change in Keratinized Tissue Width (KT) at 3- and 6-months post-surgery.
Time Frame
3- and 6-months post-surgery
Title
Change in gingival thickness (GT) at 3- and 6-months post-surgery
Time Frame
3- and 6-months post-surgery
Title
Pain and discomfort of the suture of the grafted area.
Time Frame
3- and 6-months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥18 years
periodontally and systemically healthy
presence of at least two consecutive Cairo type I (RT1) gingival recession defects
recession >2mm in depth at the buccal aspect
full-mouth plaque and bleeding score ≤20%
no previous periodontal surgery; presence of identifiable cemento-enamel junction (CEJ) (a step 1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).
Exclusion Criteria:
smokers >10 cigarettes a day
contraindications for periodontal surgery
medications known to affect the gingiva or interfere with wound healing
pregnancy and lactating females
active orthodontic therapy
caries or restorations in the area to be treated.
Patients unable to follow post-surgical medication instructions adequately.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gonzalo Blasi, MSc
Phone
0034620387688
Email
gonzaloblasi@uic.es
Facility Information:
Facility Name
International University of Catalunya
City
Barcelona
ZIP/Postal Code
08172
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Blasi
Phone
0034620387688
Email
gonzaloblasi@uic.es
Facility Name
International University of Catalunya
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Blasi
Phone
0034620387688
Email
gonzaloblasi@uic.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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