The Influence of Non-Carious Cervical Lesions on Root Coverage

Gingival Recession Clinical Trial

Official title:

The Influence of Non-Carious Cervical Lesions on Root Coverage by Means of Coronally Advanced Flap and a Connective Tissue Graft: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438094
• Other study ID #: PER-ECL-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2024
• Est. completion date: May 25, 2026

Study information

• Verified date: June 2024
• Source: Universitat Internacional de Catalunya
• Contact: Gonzalo Blasi
• Phone: 620387688
• Email: gonzaloblasi[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions (NCCLs) on the outcome of root coverage therapy. The main question it aims to answer is: In gingival recessions associated with NCCLs, characterized by an undetectable cemento-enamel junction (CEJ), reconstruction of the CEJ with a cervical composite restoration, prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft (CAF+CTG), provides similar clinical and patient-reported outcomes, as compared to the treatment of gingival recessions associated with NCCLs, characterized by a visible CEJ, with root coverage surgery only, by means of a CAF+CTG.

In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes.

Description:

In this investigation, a prospective cohort study, several key outcomes will be assessed. First, we seek to determine whether restoring the cementoenamel junction (CEJ) in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ. In addition, the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated. To our knowledge, it will be the first clinical study to use Pini Prato et al.'s surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 25, 2026
• Est. primary completion date: May 25, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Systemically healthy individuals older than 18 years old;

• Healthy periodontal status according to the AAP/EFP definition;

• Full-mouth plaque (FMPS) and bleeding scores (FMBS) = 20%;

• At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm, associated with a NCCL;

• No history of periodontal surgery at the experimental site(s).

Exclusion Criteria:

• Pregnancy or lactation;

• Self-reported smoking =10 cigarettes/day;

• Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus);

• Any medication that may interfere with wound healing;

• Prosthetic crown at experimental teeth;

• Ongoing orthodontic therapy.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.
• Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
Reconstruction of the CEJ with a composite restoration will be performed in B+ and B- defects prior to root coverage surgery. A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.

Locations

Country	Name	City	State
Spain	BLASI Clínica Dental Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Gonzalo Blasi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Root Coverage (MRC)	Mean root coverage assessed in percentage	6 months
Secondary	Complete Root Coverage (CRC)	Complete Root Coverage assessed in percentage	6 months
Secondary	Change in keratinized tissue width (?KTW)	Change in keratinized tissue width assessed digitally in mm	6 weeks, 3 months, 6 months
Secondary	Change in marginal gingival thickness (?MGT)	Change in marginal gingival thickness assessed at 1, 2, and 3 mm from the gingival margin in mm	6 weeks, 3 months, 6 months
Secondary	Change in recession depth (?RD)	Change in recession depth assessed digitally in mm	6 weeks, 3 months, 6 months
Secondary	Change in recession area (?RA)	change in recession area assessed digitally in mm^2	6 weeks, 3 months, 6 months
Secondary	Change in mucosal volume (?MV)	change in mucosal volume assessed digitally in mm^3	6 weeks, 3 months, 6 months
Secondary	Probing pocket depth (PPD)	probing pocket depth assessed clinically in mm using a periodontal probe	6 months
Secondary	Clinical attachment level (CAL)	Clinical attachment level assessed clinically in mm (sum of probing pocket depth and recession)	6 months
Secondary	Dentin sensitivity as assessed by VAS (Visual Analog Scale)	Dentin sensitivity assessed on each tooth after directing an air blast from a triple syringe at the buccal cervical areas, maintaining a distance of 1 cm for 5 seconds, using a Visual Analog Scale [0-100]	Initial, 6 months
Secondary	Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale)	Patient aesthetic satisfaction assessed using a Visual Analog Scale [0-100]	6 months