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Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession

Primary Purpose

Gingival Thickness

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CAF with SCTG and Vitamin C injection
CAF with SCTG alone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Thickness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients 18 years or older.
  2. Periodontally and systemically healthy.
  3. Buccal recession defects classified as Cairo RT1.
  4. Presence of identifiable CEJ (Zucchelli et al., 2010).
  5. Clinical indication and/or patient request for recession coverage.
  6. O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972).

Exclusion Criteria:

  1. Cairo RT2 or RT3 recession defects.
  2. Pregnant females.
  3. Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).
  4. Handicapped and mentally retarded patients.
  5. Patients undergoing radiotherapy.
  6. Teeth with cervical restorations, abrasion and malalignment.
  7. Presence of systemic disease that would affect wound healing.

Sites / Locations

  • Faculty of Oral and Dental Medicine - CURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAF with SCTG and vitamin C

CAF with SCTG

Arm Description

Coronally advanced flap with subepithelial connective tissue graft and vitamin C.

Coronally advanced flap with subepithelial connective tissue graft.

Outcomes

Primary Outcome Measures

Ginigval thickness
Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.

Secondary Outcome Measures

Root Coverage Esthetic Score
A system proposed for evaluating esthetic outcomes of root coverage procedures. The RES system evaluated five variables at 6-months after surgery: the level of the gingival margin, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color.
Early Healing Index
A system proposed for the clinical assessment of the early wound events by using a differentiated early wound healing index (EHI) (Wachtel et al., 2003).
Gingival Recession Depth (RD)
Measured from the CEJ to the most apical extension of the gingival margin.
Gingival Recession Width (RW)
Measured horizontally between the borders of the recession at the level of CEJ.
Percentage of root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Probing Depth (PD)
Measured from the gingival margin to the bottom of the gingival sulcus.
Clinical Attachment Level (CAL)
Measured from the CEJ to the bottom of the gingival sulcus.
Height of Keratinized Tissue (KTH)
Measured as the distance between the gingival margin and the mucogingival junction (MGJ). All measurements will be performed by means of the UNC periodontal probe and will be rounded up to the nearest millimeter.
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively.
Post-Surgical Patient Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.

Full Information

First Posted
November 11, 2020
Last Updated
November 16, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04632693
Brief Title
Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession
Official Title
Soft Tissue Augmentation Using Coronally Advanced Flap With Either Subepithelial Connective Tissue and Vitamin C Versus Subepithelial Connective Tissue Graft Alone in Management of RT1 Gingival Recession
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.
Detailed Description
Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAF with SCTG and vitamin C
Arm Type
Experimental
Arm Description
Coronally advanced flap with subepithelial connective tissue graft and vitamin C.
Arm Title
CAF with SCTG
Arm Type
Active Comparator
Arm Description
Coronally advanced flap with subepithelial connective tissue graft.
Intervention Type
Procedure
Intervention Name(s)
CAF with SCTG and Vitamin C injection
Intervention Description
Injection of vitamin C after CAF with SCTG aiming to increase gingival thickness in patients with RT1 gingival recession.
Intervention Type
Procedure
Intervention Name(s)
CAF with SCTG alone
Intervention Description
Coronally advanced flap with subepithelial connective tissue graft.
Primary Outcome Measure Information:
Title
Ginigval thickness
Description
Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Root Coverage Esthetic Score
Description
A system proposed for evaluating esthetic outcomes of root coverage procedures. The RES system evaluated five variables at 6-months after surgery: the level of the gingival margin, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color.
Time Frame
6 months
Title
Early Healing Index
Description
A system proposed for the clinical assessment of the early wound events by using a differentiated early wound healing index (EHI) (Wachtel et al., 2003).
Time Frame
6 months
Title
Gingival Recession Depth (RD)
Description
Measured from the CEJ to the most apical extension of the gingival margin.
Time Frame
6 months
Title
Gingival Recession Width (RW)
Description
Measured horizontally between the borders of the recession at the level of CEJ.
Time Frame
6 months
Title
Percentage of root coverage
Description
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Time Frame
6 months
Title
Probing Depth (PD)
Description
Measured from the gingival margin to the bottom of the gingival sulcus.
Time Frame
6 months
Title
Clinical Attachment Level (CAL)
Description
Measured from the CEJ to the bottom of the gingival sulcus.
Time Frame
6 months
Title
Height of Keratinized Tissue (KTH)
Description
Measured as the distance between the gingival margin and the mucogingival junction (MGJ). All measurements will be performed by means of the UNC periodontal probe and will be rounded up to the nearest millimeter.
Time Frame
6 months
Title
Post-Operative Pain
Description
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively.
Time Frame
2 weeks
Title
Post-Surgical Patient Satisfaction
Description
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Cairo RT1. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972). Exclusion Criteria: Cairo RT2 or RT3 recession defects. Pregnant females. Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009). Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Teeth with cervical restorations, abrasion and malalignment. Presence of systemic disease that would affect wound healing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Albert A. Zaki, MSc
Phone
01274805636
Email
andrew.anwar@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine - CU
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Albert A. Zaki, MSc
Phone
01274805636
Email
andrew.anwar@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession

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