L-PRF Versus Connective Tissue Graft Associated to Coronally Advanced Flap in Gingival Recession Treatment

NCT04165044 | Completed

• 1 other identifier: L-PRF in gingival recession
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Nowadays, the use of connective tissue graft associated to the coronally advanced flap is considered the "gold standard" for localized gingival recession treatment. However, this technique requires a donor site, which can be associated with greater morbidity. The use of platelet concentrates, particularly the Leukocytes- and Platelets Rich Fibrin (L-PRF), it has emerged as an alternative for gingival recession treatment, due to its properties which enhance the regenerative process. Therefore, the purpose of this study was to evaluate and to compare the effect obtained with L-PRF versus connective tissue graft (CTG) associated to the Coronally Advanced Flap (CAF) in the treatment of Miller class I or II localized gingival recessions. Methods: A randomized controlled clinical trial of parallel groups (1:1) with 17 recessions in each group was performed. Control group (CAF + CTG) and test group (CAF + L-PRF). In each group the following variable were measured: postoperative pain and incidence of post-surgical complications at 24-48-72 hours, gingival recession depth (RD), gingival recession width (RW), gingival thickness (GT), probing depth (PD), clinical insertion level (NIC), keratinized tissue height (KTH) before treatment and after 1, 3 and 6 months of root covering surgery and the root coverage esthetic score (RES) at 6 months after treatment.

Conditions

Gingival Recession, Localized

Keywords

Leukocyte and Platelet Rich Fibrin; Connective tissue graft; Gingival recession

Outcome Measures

Primary Outcomes (1)

• Change in Recession depth (RD)

  pre-operative RD - post-operative RD in millimeters

  At 1 month, 3 months and 6 months

Secondary Outcomes (9)

• Change in Recession wide (RW)

  At 1 month, 3 months and 6 months

• Change in Percentage of root coverage

  At 1 month, 3 months and 6 months

• Change in Gingival thickness (GT)

  At 1 month, 3 months and 6 months

• Change in Probing depth (PD)

  At 1 month, 3 months and 6 months

• Change in Clinical attachment level (CAL)

  At 1 month, 3 months and 6 months

Study Arms (2)

L-PRF+CAF

ACTIVE COMPARATOR

Leukocyte and Platelet Rich Fibrin plus Coronally Advanced Flap

Procedure: Leukocyte and Platelet Rich Fibrin plus Coronally Advanced Flap

CTG+CAF

ACTIVE COMPARATOR

Connective Tissue graft plus Coronally Advanced Flap

Procedure: Connective tissue graft plus Coronally Advanced Flap

Interventions

Leukocyte and Platelet Rich Fibrin plus Coronally Advanced Flap PROCEDURE

The Coronally advanced flap was made following the protocol described by Zucchelli et al. in 2007. (39). When the margin of the flap was able to passively extend until more coronal of the CEJ the coronal mobilization of the flap was considered satisfactory. A double L-PRF membrane was positioned at the level of CEJ, getting the stabilization with 5-0 resorbable suture. After that, the flap was coronally advanced and stabilized with interrupted sutures (5-0 resorbable) anchored to incisal contact points (mesial and distal) created with a flowable, light-curing resin material in the treated tooth. Finally, gentle pressure over the area with a moistened gauze with saline solution was performed.

Also known as: L-PRF + CAF

L-PRF+CAF

Connective tissue graft plus Coronally Advanced Flap PROCEDURE

The Coronally advanced flap was made following the protocol described by Zucchelli et al. in 2007. (39). When the margin of the flap was able to passively extend until more coronal of the CEJ the coronal mobilization of the flap was considered satisfactory. Then connective tissue graft obtained from the palate was positioned at the level of CEJ, getting the stabilization with 5-0 resorbable suture. After that, the flap was coronally advanced and stabilized with interrupted sutures (5-0 resorbable) anchored to incisal contact points (mesial and distal) created with a flowable, light-curing resin material in the treated tooth. Finally, gentle pressure over the area with a moistened gauze with saline solution was performed.

Also known as: CTG + CAF

CTG+CAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients
• Older than18 years
• At least one localized Miller class I or II gingival recession higher than 3mm at buccal aspect of anterior/premolar area
• An identifiable cement-enamel junction (CEJ)
• Without bleeding on probing (BOP)
• Pulp vitality

You may not qualify if:

• Smokers
• Pregnancy
• Active periodontal disease
• Previous periodontal surgical procedures in the recession area
• Coagulation disorders
• Anticoagulant treatment
• Patients who cannot comply the study and/or maintenance visits.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

Universidad de Los Andes

Santiago, 7550000, Chile

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Leukocyte Count

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Catherine Andrade

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinician who performed the measurements as well as the statistic were blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled clinical trial of parallel group (1:1)

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 15, 2019
• Study Start: April 1, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-11

Locations

CL (1)