Clinical trial NCT03883438: Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions
Official title: Coronally Advanced Flap and Envelope Type of Flap Plus Acellular Dermal Matrix Graft for the Treatment of Thin Phenotype Multiple Recession Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Generalized
Keywords: Gingival recession
Therapy
Surgery
Tooth root
Surgical flaps
Acellular dermis
Lead sponsor: Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Sponsor class: OTHER
Collaborators: name: Altinbas University
name: Universidade Ibirapuera
name: Universidad El Bosque, Bogotá
First posted: 2019-03-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 22 patients with 55 recessions were included in this single blind randomized controlled trial. Each patient had at least two recessions with a depth of ≥ 3 mm (Miller Class I\&II) in the upper jaw. The entry criteria were esthetic indication for root coverage; absence of caries or restorations at the selected sites; no history of previous mucogingival therapy; being a non-smoker and a systemically healthy patient.
Primary purpose: TREATMENT

Brief summary: Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft

Detailed description: The aim of this study was to evaluate the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap (CAF) and acellular dermal matrix graft (ADMG) in 22 eligible participants.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients
* Miller Class I \& II multiple buccal recession defects ≥ 3 mm on maxillary incisors, canines or premolars
* Esthetic indication for root coverage
* Probing depth \< 3mm at the recession sites

Exclusion Criteria:

* Smokers
* Pregnancy
* Bruxism and occlusal trauma
* Previous root coverage procedure
* Endodontically treated teeth at the recession sites
* Caries or restorations at the recession sites
* Use of antibiotics over the previous 3 months prior to treatment

Primary outcomes:
measure: Complete root coverage
timeFrame: 12 months
measure: Root coverage esthetic score
timeFrame: 12 months
measure: Patient satisfaction score
timeFrame: 12 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 12 months
measure: Gingival Index
timeFrame: 12 months
measure: Bleeding on Probing
timeFrame: 12 months
measure: Probing Depth
timeFrame: 12 months
measure: Clinical Attachment Level
timeFrame: 12 months
measure: Recession Depth
timeFrame: 12 months
measure: Recession Width
timeFrame: 12 months
measure: Gingival Thickness
timeFrame: 12 months
measure: Keratinized Tissue Width
timeFrame: 12 months
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
city: San Paolo
country: Brazil
facility: Ibirapuera University
city: Bogota
country: Colombia
facility: El Bosque University
city: Istanbul
country: Turkey
facility: Altinbas University
Study officials:
affiliation: Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
name: Cavid Ahmedbeyli, PhD
role: PRINCIPAL_INVESTIGATOR
References: