## Protocol Section
### Identification Module
**NCT ID:** NCT06438094

**Brief Title:** The Influence of Non-Carious Cervical Lesions on Root Coverage: A Prospective Cohort Study

**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

#### Organization Study ID Info
**ID:** PER-ECL-2022-01
#### Organization
**Class:** OTHER
**Full Name:** Universitat Internacional de Catalunya
### Status Module
#### Completion Date
**Date:** 2026-05-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gonzalo Blasi

#### Responsible Party

**Investigator Affiliation:** Universitat Internacional de Catalunya

**Investigator Full Name:** Gonzalo Blasi

**Investigator Title:** DDS, MS, PhD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Gingival Recessions Associated With Non-carious Cervical Lesions

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** There are two treatments but they are based on the tooth-level

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 56

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only.

**Intervention Names:**

- Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft

**Label:** Type A gingival recession defects

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery.

**Intervention Names:**

- Procedure: 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

**Label:** Type B gingival recession defects

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Type A gingival recession defects

**Description:** A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.

**Name:** Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Type B gingival recession defects

**Description:** 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.

**Name:** 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

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Mean root coverage assesses in percentage

**Measure:** Mean Root Coverage (MRC)

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Complete Root Coverage assessed in percentage

**Measure:** Complete Root Coverage (CRC)

**Time Frame:** 6 months

**Description:** change in keratinized tissue width assessed digitally in mm

**Measure:** change in keratinized tissue width (ΔKTW)

**Time Frame:** 6 weeks, 3 months, 6 months

**Description:** change in marginal gingival thickness assessed at 1,2, and 3 mm from the gingival margin in mm

**Measure:** change in marginal gingival thickness (ΔMGT)

**Time Frame:** 6 weeks, 3 months, 6 months

**Description:** change in recession depth assessed digitally in mm

**Measure:** change in recession depth (ΔRD)

**Time Frame:** 6 weeks, 3 months, 6 months

**Description:** change in recession area assessed digitally in mm\^2

**Measure:** change in recession area (ΔRA)

**Time Frame:** 6 weeks, 3 months, 6 months

**Description:** change in mucosal volume assessed digitally in mm\^3

**Measure:** change in mucosal volume (ΔMV)

**Time Frame:** 6 weeks, 3 months, 6 months

**Description:** probing pocket depth assessed clinically in mm using a periodontal probe

**Measure:** probing pocket depth (PPD)

**Time Frame:** 6 months

**Description:** clinical attachment level assessed clinically in mm

**Measure:** clinical attachment level (CAL)

**Time Frame:** 6 months

**Description:** dentin sensitivity assessed on each tooth using a Visual Analog Scale

**Measure:** dentin sensitivity

**Time Frame:** initial, 6 months

**Description:** Patient aesthetic satisfaction assessed using a Visual Analog Scale

**Measure:** Patient aesthetic satisfaction

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gonzaloblasi@uic.es

**Name:** Gonzalo Blasi

**Phone:** 620387688

**Role:** CONTACT

**Contact 2:**

**Email:** lory.abrahamian@uic.es

**Name:** Lory Abrahamian

**Phone:** 722528012

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Email:** gonzaloblasi@uic.es

- **Name:** Gonzalo Blasi

- **Phone:** 620387688

- **Role:** CONTACT

**Country:** Spain

**Facility:** BLASI Clínica Dental Barcelona

**Status:** RECRUITING

**Zip:** 08021

#### Overall Officials

**Official 1:**

**Affiliation:** Universitat Internacional de Catalunya

**Name:** Gonzalo Blasi

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Universitat Internacional de Catalunya

**Name:** José Nart

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005882

- Term: Gingival Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000055093

- Term: Periodontal Atrophy

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9001

- Name: Gingival Recession

- Relevance: HIGH

- As Found: Gingival Recession

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: HIGH

- As Found: Cervical Lesions

- ID: M8994

- Name: Gingival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M28025

- Name: Periodontal Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005889

- Term: Gingival Recession

- ID: D000002577

- Term: Uterine Cervical Diseases

### Misc Info Module

- Version Holder: 2024-05-31
