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Influence of Anatomical Factors Upon Root Coverage

Primary Purpose

Gingival Recession, Gingival Diseases, Periodontal Attachment Loss

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Coronally advanced flap and connective tissue graft
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥18 years.
  • Periodontally and systemically healthy.
  • Presence of Miller class I and II GR defects or class III with no interproximal clinical attachment loss.
  • Recession >2mm in depth at the buccal aspect.
  • Full-mouth plaque and bleeding score ≤20%.
  • No previous periodontal surgery.
  • Presence of identifiable CEJ (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).

Exclusion Criteria:

  • Tobacco smoking of ≥10 cigarettes a day.
  • Contraindications for periodontal surgery.
  • Medications known to affect the gingiva or interfere with wound healing.
  • Pregnancy.
  • Active orthodontic therapy.
  • caries or restorations in the area to be treated.

Sites / Locations

  • International University of Catalunya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gingival recession treatment

Arm Description

Gingival recession treatment by means of a coronally advanced flap and a connective tissue graft

Outcomes

Primary Outcome Measures

Complete Root Coverage
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.

Secondary Outcome Measures

Mean Root Coverage
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.

Full Information

First Posted
March 21, 2021
Last Updated
March 21, 2021
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04813302
Brief Title
Influence of Anatomical Factors Upon Root Coverage
Official Title
Influence of Anatomical Factors Upon Root Coverage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
March 15, 2021 (Actual)

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
Introduction: Gingival recession is a lesion characterized by the loss of attachment of root surface of the tooth, resulting in an apical migration of the gingival margin that occasionally generates aesthetic problems, hypersensitivity and difficulty in maintaining proper hygiene. Several anatomical factors have been associated both with the incidence and progression of gingival recession and with the prognosis of the surgical treatments proposed for its correction. These factors include the absence of keratinized tissue, the gingival phenotype, root prominence and shallow vesrtibular depth. Objectives: The objective of the study is to evaluate, through a series of prospective cases, the influence of each of the anatomical factors on the success of root coverage. Methods: 20 patients with gingival recession defects will be treated with CAF+CTG using various autogenous gingival graft. Three-dimensional analysis of superimposed preoperative and postoperative images will be performed. Linear and surface root coverage will be calculated and correlated to various anatomical parameters such as vestibular depth and root prominence. A multilevel statistical analysis will be conducted, adjusting for the correlation among multiple observations.
Detailed Description
- Pre-surgical treatment: Initial periodontal therapy will be performed 1 month prior to surgery. Patients will receive a pre-surgical prophylaxis, oral hygiene instructions and elimination of toothbrushing traumatic technique, if needed. They will be taught to use a toothbrush of medium hardness applying Roll brushing technique. - Surgical treatment: In brief description, CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized and the exposed root surfaces will be treated with pre-conditioning EDTA (Straumann PrefGel®) for 2 minutes. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft (22), cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae (7-0 Polyglactin 910, Vycril, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA) and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ (6-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA), followed by interrupted sutures to close the releasing incisions. Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and patients will be instructed to rinse with Chlorhexidine three times per day for 2 weeks. Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures. - Post-surgical instructions and infection control: Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and patients will be instructed to rinse with Chlorhexidine 0.12% two times per day for 2 weeks. Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures. - Data collection: A guidebook will be prepared to systematize the procedures for sample and data collection. The data will be later transferred to a computerized database (Epidata®, Odense, Denmark, Europe). A) Sociodemographic data An interview will be conducted during the pre-surgical visit to obtain information regar- ding age, sex, medical history, use of medication, exposure to tobacco, pregnancy and previous periodontal surgeries. B) Clinical measurements Probing depth (PD) and keratinized tissue width (KTW) will be measured using a periodontal probe (PCP UNC 15, Hu-Friedy, Chicago, IL, USA). KTW will be measured at the most apical point in the GM to the mucogingival junction at the mid-buccal site to the nearest millimeter. KTT will be measured 1.5mm and 3mm apical to the GM using an injection needle, perpendicular to the tissues surface and a silicon stop over the gingival surface and fixed with a cyanoacrylic adhesive (23). Clinical attachment level will be calculated as REC + PD. C) Digital measurements All patients will be scanned and their models will be digitalized with an optical 3D measurement system (3Shape, Erlangen, Germany) creating surface tessellation language (STL) files while a bilateral retractor is placed in the mouth and teeth are held lightly in occlusion. The acquired data will be transferred into a digital imaging software (3Shape Trios®, Erlangen, Germany) in which patient name will be substituted for a random ID number in order to anonymize the data. Baseline and corresponding follow-up scans of each clinical case will be then virtually superimposed and matched into one common coordinate system (Geomagic, 3D Systems, Research Triangle Park, NC, USA) using the tool Control X. By using the buccal surfaces of the concerned teeth as reference points for the superpositioning of the different time points (pre-operative and post-operative), this approach will allow for precise evaluation of dimensional soft tissue alterations over time by a blinded examiner. Vestibular depth will be measured from the GM to the point of greatest concavity of the mucobuccal fold. The digital linear and volumetric measurements and assessment will be performed by a single, calibrated examiner for the surgical. The examiner will be trained on 15 casts with gingival recessions who will not be included in this study. This examination will be repeated 24 h later; differences of ≤0.5 mm in at least 90% of the cases will be considered to be acceptable. The following measurements will be taken: All clinical measurements and volumetric evaluations of the soft will be performed at baseline, 3 months and at 6 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Gingival Diseases, Periodontal Attachment Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gingival recession treatment
Arm Type
Experimental
Arm Description
Gingival recession treatment by means of a coronally advanced flap and a connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap and connective tissue graft
Intervention Description
CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft, cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ , followed by interrupted sutures to close the releasing incisions.
Primary Outcome Measure Information:
Title
Complete Root Coverage
Description
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Root Coverage
Description
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.
Time Frame
6 months

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 Miller class I and II GR defects or class III with no interproximal clinical attachment loss. Recession >2mm in depth at the buccal aspect. Full-mouth plaque and bleeding score ≤20%. No previous periodontal surgery. Presence of identifiable CEJ (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted). Exclusion Criteria: Tobacco smoking of ≥10 cigarettes a day. Contraindications for periodontal surgery. Medications known to affect the gingiva or interfere with wound healing. Pregnancy. Active orthodontic therapy. caries or restorations in the area to be treated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Nart, DDS PhD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Chair
Facility Information:
Facility Name
International University of Catalunya
City
Barcelona
ZIP/Postal Code
08172
Country
Spain

12. IPD Sharing Statement

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Influence of Anatomical Factors Upon Root Coverage

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