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Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession

Primary Purpose

Gingival Recession, Recession, Gingival, Thin-gingiva

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Root coverage using coronally advanced flap combined with micro-needling
coronally advanced flap combined with Alloderm
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring RT1, Recession, micro-needling, micro-needles, Coronally Advanced Flap, Alloderm

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient consulting in the outpatient clinic.

    • Able to tolerate the study procedures.
    • Patient ready to perform oral hygiene instructions.
    • Compliance with the maintenance program.
    • Provide informed consent.
    • Accepts the 6 months follow-up period
  • Mature permanent tooth.
  • Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
  • Presence of identifiable Cemento-enamel Junction.
  • RT1 facial recession defect of ≥3 mm.
  • Clinical indication and/or patient request for recession coverage

Exclusion Criteria:

  • Medically compromised patients.

    • use of any drugs that might lead to gingival enlargement
    • Pregnant or nursing women.
    • Uncooperative patients.
    • Smokers.
  • Teeth with malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.

    • Cairo Recession Type 3 (RT3) recession defects.
    • Teeth with active orthodontic treatment.
    • Previous periodontal surgery.

Sites / Locations

  • Faculty of Dentistry - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Root coverage using coronally advanced flap combined with micro-needling

coronally advanced flap combined with Alloderm

Arm Description

modified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing

modified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it.

Outcomes

Primary Outcome Measures

Gingival thickness (GT) in mm
Gingival thickness (GT) will be specified at a mid-buccal location approximately 1 mm apical to the probing depth (PD) level with a #15 endodontic spreader. The reamer will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface and fixed by a drop of cyanoacrylate adhesive; after careful removal of the reamer, penetration depth will be measured with a caliper to the nearest 0.1 mm gingival thickness changes will be calculated after 6 months

Secondary Outcome Measures

Keratinized tissue width (KTW) in mm
Keratinized tissue (KT) will be measured from the most apical point of the gingival margin to the mucogingival junction measurements will be recorded at baseline and after 6 months
Clinical Attachment Level (CAL) in mm
Will be measured from the Cemento-enamel Junction to the bottom of the gingival sulcus at baseline and 6 months
Gingival Recession Depth (RD) in mm
Will be measured from the Cemento-enamel Junction to the most apical extension of the gingival margin.
Gingival Recession Width (RW) in mm
Will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.
Percentage of root coverage
Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.

Full Information

First Posted
July 20, 2022
Last Updated
July 20, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05470660
Brief Title
Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession
Official Title
The Effect of Coronally Advanced Flap With Acellular Dermal Matrix (Alloderm) Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (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

5. Study Description

Brief Summary
This study aims to assess the effect of micro-needling together with coronally advanced flap procedure on the gain of gingival thickness (GT) and keratinized tissue width (KTW) and compare it to Alloderm with coronally advanced flap procedure in the management of thin periodontal phenotype associated with recession type 1 (RT1)
Detailed Description
Gingival or periodontal diseases were found to occur more likely in patients with a thin gingival biotype. The periodontal phenotype was also found to show stronger correlation with gingival thickness rather than keratinized tissue width and papilla height. Moreover, the thin gingiva was usually found to be associated with thin bony plate with potential for dehiscence and fenestration and hence was thought to be at risk for recession after trauma. Several techniques have been recommended for the treatment of gingival recession. One of the most predictable outcome is associated with the use of a coronally advanced flap and acellular dermal matrix graft. Treatment of thin periodontal phenotype through the conjunction of i-PRF and micro-needling may be a first move of the non-surgical approach for improving the gingival thickness. Micro-needling was proved to be generally an effective and safe therapeutic option for numerous dermatologic conditions as clinical improvement of scars, striae, and rhytids with appropriate recovery and limited side effects. The controlled dermal wounding and stimulation of the wound healing cascade through Micro-needling was found to enhance collagen production and thus was responsible for the clinical results obtained. Therefore, this study will be aiming to compare the effect of micro-needling on the gingival thickness in root coverage procedures. It will also provide an insight of its effect on the patient related factors and the root coverage parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Recession, Gingival, Thin-gingiva
Keywords
RT1, Recession, micro-needling, micro-needles, Coronally Advanced Flap, Alloderm

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Root coverage using coronally advanced flap combined with micro-needling
Arm Type
Experimental
Arm Description
modified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing
Arm Title
coronally advanced flap combined with Alloderm
Arm Type
Active Comparator
Arm Description
modified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it.
Intervention Type
Procedure
Intervention Name(s)
Root coverage using coronally advanced flap combined with micro-needling
Intervention Description
modified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing.
Intervention Type
Procedure
Intervention Name(s)
coronally advanced flap combined with Alloderm
Intervention Description
modified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it.
Primary Outcome Measure Information:
Title
Gingival thickness (GT) in mm
Description
Gingival thickness (GT) will be specified at a mid-buccal location approximately 1 mm apical to the probing depth (PD) level with a #15 endodontic spreader. The reamer will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface and fixed by a drop of cyanoacrylate adhesive; after careful removal of the reamer, penetration depth will be measured with a caliper to the nearest 0.1 mm gingival thickness changes will be calculated after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Keratinized tissue width (KTW) in mm
Description
Keratinized tissue (KT) will be measured from the most apical point of the gingival margin to the mucogingival junction measurements will be recorded at baseline and after 6 months
Time Frame
6 months
Title
Clinical Attachment Level (CAL) in mm
Description
Will be measured from the Cemento-enamel Junction to the bottom of the gingival sulcus at baseline and 6 months
Time Frame
6 months
Title
Gingival Recession Depth (RD) in mm
Description
Will be measured from the Cemento-enamel Junction to the most apical extension of the gingival margin.
Time Frame
6 months
Title
Gingival Recession Width (RW) in mm
Description
Will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient consulting in the outpatient clinic. Able to tolerate the study procedures. Patient ready to perform oral hygiene instructions. Compliance with the maintenance program. Provide informed consent. Accepts the 6 months follow-up period Mature permanent tooth. Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%. Presence of identifiable Cemento-enamel Junction. RT1 facial recession defect of ≥3 mm. Clinical indication and/or patient request for recession coverage Exclusion Criteria: Medically compromised patients. use of any drugs that might lead to gingival enlargement Pregnant or nursing women. Uncooperative patients. Smokers. Teeth with malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth. Cairo Recession Type 3 (RT3) recession defects. Teeth with active orthodontic treatment. Previous periodontal surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salma Ezzat, BDs
Phone
+201111101489
Email
salma.ezzat@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry - Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo University

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28796657
Citation
Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
Results Reference
background
PubMed Identifier
18724847
Citation
Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
Results Reference
background
PubMed Identifier
15455743
Citation
Cortes Ade Q, Martins AG, Nociti FH Jr, Sallum AW, Casati MZ, Sallum EA. Coronally positioned flap with or without acellular dermal matrix graft in the treatment of Class I gingival recessions: a randomized controlled clinical study. J Periodontol. 2004 Aug;75(8):1137-44. doi: 10.1902/jop.2004.75.8.1137.
Results Reference
background

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Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession

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