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

NCT05470660 | Unknown

• 1 other identifier: PER331
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Gingival Recession; Recession, Gingival; Thin-gingiva

Keywords

RT1; Recession; micro-needling; micro-needles; Coronally Advanced Flap; Alloderm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Keratinized tissue width (KTW) in mm

  6 months

• Clinical Attachment Level (CAL) in mm

  6 months

• Gingival Recession Depth (RD) in mm

  6 months

• Gingival Recession Width (RW) in mm

  6 months

• Percentage of root coverage

  6 months

Study Arms (2)

Root coverage using coronally advanced flap combined with micro-needling

EXPERIMENTAL

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

coronally advanced flap combined with Alloderm

ACTIVE COMPARATOR

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

Interventions

Root coverage using coronally advanced flap combined with micro-needling PROCEDURE

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.

Root coverage using coronally advanced flap combined with micro-needling

coronally advanced flap combined with Alloderm PROCEDURE

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.

coronally advanced flap combined with Alloderm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

Related Publications (3)

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

  PMID: 28796657 BACKGROUND

• 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.

  PMID: 18724847 BACKGROUND

• 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.

  PMID: 15455743 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Salma Ezzat, BDs

CONTACT

+201111101489; salma.ezzat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator. Salma Ezzat

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

EG (1)