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Connective Tissue Graft From the Tuberosity Area in Combination With Coronally Advanced Flap for Root Coverage.

Primary Purpose

Gingival Recession

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Periodontal surgery with CAF+tSCTG
Periodontal surgery with CAF+pSCTG
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Root coverage, Periodontal plastic surgery

Eligibility Criteria

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

Inclusion Criteria: Presence of a class RT1 recession; age > 18 years; systemic health conditions that do not affect the periodontium; Non smoker; FMPS and FMBS values < 20% before the surgical procedure; absence of implants or subgingival restorations in the sites to be treated; presence of adequate tissue distal to the last maxillary molar.

Sites / Locations

  • Michele Paolantonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAF+tSCTG

CAF+pSCTG

Arm Description

21 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness.A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosit. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

21 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm,2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession. Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa. The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The harvesting of the epithelial-connective graft will be performed at the level of the palate between the canine and the first molar.The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

Outcomes

Primary Outcome Measures

Complete root coverage
Percentage of experimental sites that achieved complete root surface coverage.

Secondary Outcome Measures

Gingival recession
Distance from cementoenamel junction and gingival margin
Clinical attachment level
Distance between cementoenamel junction(CEJ) and depth of the pocket
Pocket depth
Distance between gingival margin and bottom of the pocket
Gingival thickness
Gingival tissue thickness 2 mm apical to the recession
Keratinized tissue height
Distance between gingival margin and Mucogingival Junction

Full Information

First Posted
March 13, 2023
Last Updated
March 13, 2023
Sponsor
G. d'Annunzio University
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1. Study Identification

Unique Protocol Identification Number
NCT05783258
Brief Title
Connective Tissue Graft From the Tuberosity Area in Combination With Coronally Advanced Flap for Root Coverage.
Official Title
Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Palatal Subepithelial Connective Tissue Graft (SCTG) or a Connective Tissue Graft From the Tuberosity Area: a Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
May 29, 2023 (Anticipated)
Study Completion Date
May 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

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
The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the palatine area or from the maxillary retromolar tubeosity area in the treatment of RT1 recessions by coronally advanced flap. A total of 42 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+pSCTG). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 3 months after the surgical procedure (T1). In addition, the different morbidity of the two surgical techniques was also evaluated using the VAS scale values recorded in the first 2 weeks following surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Root coverage, Periodontal plastic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAF+tSCTG
Arm Type
Experimental
Arm Description
21 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness.A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosit. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.
Arm Title
CAF+pSCTG
Arm Type
Active Comparator
Arm Description
21 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm,2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession. Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa. The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The harvesting of the epithelial-connective graft will be performed at the level of the palate between the canine and the first molar.The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery with CAF+tSCTG
Intervention Description
Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery with CAF+pSCTG
Intervention Description
Coronally advanced flap and subepithelial connective tissue graft harvested from the palate.
Primary Outcome Measure Information:
Title
Complete root coverage
Description
Percentage of experimental sites that achieved complete root surface coverage.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gingival recession
Description
Distance from cementoenamel junction and gingival margin
Time Frame
3 months
Title
Clinical attachment level
Description
Distance between cementoenamel junction(CEJ) and depth of the pocket
Time Frame
3 months
Title
Pocket depth
Description
Distance between gingival margin and bottom of the pocket
Time Frame
3 months
Title
Gingival thickness
Description
Gingival tissue thickness 2 mm apical to the recession
Time Frame
3 months
Title
Keratinized tissue height
Description
Distance between gingival margin and Mucogingival Junction
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of a class RT1 recession; age > 18 years; systemic health conditions that do not affect the periodontium; Non smoker; FMPS and FMBS values < 20% before the surgical procedure; absence of implants or subgingival restorations in the sites to be treated; presence of adequate tissue distal to the last maxillary molar.
Facility Information:
Facility Name
Michele Paolantonio
City
Pescara
ZIP/Postal Code
65121
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Connective Tissue Graft From the Tuberosity Area in Combination With Coronally Advanced Flap for Root Coverage.

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