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

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession; Recession, Gingival; Thin-gingiva
• Intervention / Treatment: Procedure: Root coverage using coronally advanced flap combined with micro-needling; Procedure: coronally advanced flap combined with Alloderm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salma Ezzat, BDs; Phone Number: +201111101489; Email: salma.ezzat@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Root coverage using coronally advanced flap combined with micro-needling; 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	Procedure: Root coverage using coronally advanced flap combined with micro-needling; 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.
Active Comparator: coronally advanced flap combined with Alloderm; 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.	Procedure: coronally advanced flap combined with Alloderm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	6 months
Gingival Recession Width (RW) in mm	Will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.	6 months
Percentage of root coverage	Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Alloderm; RT1; Recession; micro-needling; micro-needles; Coronally Advanced Flap
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: PER331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No