Gingival RecessionNCT06438094
The Influence of Non-Carious Cervical Lesions on Root Coverage
A study testing Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft and 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 in people with Gingival Recession, run by Gonzalo Blasi at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft and 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 of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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
- Gingival Recession
- Being tested
- Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft, 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
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graftProcedure or 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.
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 graftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Type A gingival recession defects | Experimental | Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only. Receives: Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft |
| Type B gingival recession defects | Experimental | Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Root Coverage (MRC)
Mean root coverage assessed in percentage
Measured: 6 months
Secondary outcomes (10)
Complete Root Coverage (CRC)
Complete Root Coverage assessed in percentage
Measured: 6 months
Change in keratinized tissue width (ΔKTW)
Change in keratinized tissue width assessed digitally in mm
Measured: 6 weeks, 3 months, 6 months
Change in marginal gingival thickness (ΔMGT)
Change in marginal gingival thickness assessed at 1, 2, and 3 mm from the gingival margin in mm
Measured: 6 weeks, 3 months, 6 months
Change in recession depth (ΔRD)
Change in recession depth assessed digitally in mm
Measured: 6 weeks, 3 months, 6 months
Change in recession area (ΔRA)
change in recession area assessed digitally in mm^2
Measured: 6 weeks, 3 months, 6 months
Change in mucosal volume (ΔMV)
change in mucosal volume assessed digitally in mm^3
Measured: 6 weeks, 3 months, 6 months
Probing pocket depth (PPD)
probing pocket depth assessed clinically in mm using a periodontal probe
Measured: 6 months
Clinical attachment level (CAL)
Clinical attachment level assessed clinically in mm (sum of probing pocket depth and recession)
Measured: 6 months
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]
Measured: Initial, 6 months
Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale)
Patient aesthetic satisfaction assessed using a Visual Analog Scale [0-100]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start26 May 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are two treatments but they are based on the tooth-level
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonzalo Blasi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
- Investigators
- Gonzalo Blasi, Study director, Universitat Internacional de CatalunyaJosé Nart, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438094
- Sponsor's protocol ID
- PER-ECL-2022-01
- Status last verified
- Apr 2026
- First submitted
- 26 May 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06438094
- Acronym / sponsor ID
- PER-ECL-2022-01
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gonzalo BlasiUniversity, hospital or other
- Study start
- 26 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two treatments but they are based on the tooth-level
| Arm | Type | Receives |
|---|---|---|
| Type A gingival recession defects | Experimental | Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graftGingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only. |
| Type B gingival recession defects | Experimental | 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 graftGingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graftA root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate. | Procedure or surgery | Type A gingival recession defects |
| 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 graftReconstruction 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. | Procedure or surgery | Type B gingival recession defects |
Primary outcome
Mean Root Coverage (MRC)
Time frame: 6 months
Mean root coverage assessed in percentage
10 secondary outcomes
Complete Root Coverage (CRC)
Time frame: 6 months
Change in keratinized tissue width (ΔKTW)
Time frame: 6 weeks, 3 months, 6 months
Change in marginal gingival thickness (ΔMGT)
Time frame: 6 weeks, 3 months, 6 months
Change in recession depth (ΔRD)
Time frame: 6 weeks, 3 months, 6 months
Change in recession area (ΔRA)
Time frame: 6 weeks, 3 months, 6 months
Change in mucosal volume (ΔMV)
Time frame: 6 weeks, 3 months, 6 months
Probing pocket depth (PPD)
Time frame: 6 months
Clinical attachment level (CAL)
Time frame: 6 months
Dentin sensitivity as assessed by VAS (Visual Analog Scale)
Time frame: Initial, 6 months
Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzalo Blasi study director
Universitat Internacional de Catalunya
José Nart principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft and 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 in people with Gingival Recession, run by Gonzalo Blasi at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Root Coverage (MRC) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.