One- Versus Two-Stage Aesthetic Crown Lengthening

May 26, 2020 updated by: Universidad Complutense de Madrid

One- Versus Two-Stage Aesthetic Crown Lengthening for Restorative Purposes: A Randomized Controlled Trial.

This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than eighteen years of age;
  • more than 20 teeth in the mouth;
  • with full mouth plaque and bleeding scores lower than 15%; and
  • without probing pocket depth and/or attachment loss >4 mm

Exclusion Criteria:

  • Pregnant women or breastfeeding
  • smokers
  • treated with antimicrobial and/or anti-inflammatory drugs within two months prior to entering the study
  • currently undergoing orthodontic therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Crown Lengthening; CCL
Using the surgical guide, submarginal internal bevel incisions were performed on the buccal aspect of the affected teeth. A full-thickness flap was raised up to the mucogingival junction (Dominguez et al., 2020). Ostectomy and osteoplasty were carried out by means of rotatory instruments and surgical chisels, as necessary, to achieve the necessary space between the bone crest and the restorative margin according to the presurgical plan. The CEJ was not the reference point since, in many cases, the position of the final margin of the restoration was planned apical to the actual position of the CEJ. Exposed root surfaces were carefully instrumented manually with curettes and, finally, vertical internal mattress sutures were placed to position the gingival margin at the level of the margin of the planned restoration. Sutures were removed after 7 days.
Other: Conventional Crown Lengthening (CCL)
Using the surgical guide, submarginal internal bevel incisions were performed on the buccal aspect of the affected teeth. A full-thickness flap was raised up to the mucogingival junction (Dominguez et al., 2020). Ostectomy and osteoplasty were carried out by means of rotatory instruments and surgical chisels, as necessary, to achieve the necessary space between the bone crest and the restorative margin according to the presurgical plan. The CEJ was not the reference point since, in many cases, the position of the final margin of the restoration was planned apical to the actual position of the CEJ. Exposed root surfaces were carefully instrumented manually with curettes and, finally, vertical internal mattress sutures were placed to position the gingival margin at the level of the margin of the planned restoration. Sutures were removed after 7 days
Experimental: Two-stage Crown Lengthening (SCL)
In the first surgical intervention, intrasulcular incisions were performed and a full thickness flap was raised up to the mucogingival junction. Ostectomy and osteoplasty were performed to establish the space for supracrestal tissue attachment, following the restorative plan and using the presurgical blueprint as the reference to determine the final position of the restoration margin, instead of the CEJ (Lee, 2004). Then the flaps were repositioned and secured with internal mattress sutures, placing the gingival margin at the original level. Sutures were removed at 7 days. In the second stage, after 3-4 months, minor gingival recontouring was performed, if necessary, to attain the desired gingival margin position according to the presurgical plan
Other: Two-stage Crown Lengthening (SCL)
In the first surgical intervention, intrasulcular incisions were performed and a full thickness flap was raised up to the mucogingival junction. Ostectomy and osteoplasty were performed to establish the space for supracrestal tissue attachment, following the restorative plan and using the presurgical blueprint as the reference to determine the final position of the restoration margin, instead of the CEJ (Lee, 2004). Then the flaps were repositioned and secured with internal mattress sutures, placing the gingival margin at the original level. Sutures were removed at 7 days. In the second stage, after 3-4 months, minor gingival recontouring was performed, if necessary, to attain the desired gingival margin position according to the presurgical plan.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
T1-T4
Time Frame: Baseline-12 months
The difference in mm between the ideal gingival margin (T1) and the position of the gingival margin at 12 months (T4).
Baseline-12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Crown Length
Time Frame: At baseline, 6- and 12-month
Distance from the gingival margin to the incisal edge on the midbuccal.Measured in mm.
At baseline, 6- and 12-month
Amount of keratinized tissue
Time Frame: At baseline, 6- and 12-month
Distance from the gingival margin to the mucogingival junction on the midbuccal.Measured in mm.
At baseline, 6- and 12-month
Gingival display upon smiling
Time Frame: At baseline, 6- and 12-month
Distance from the gingival margin of the central incisors to the lower edge of the upper lip. Measured in mm.
At baseline, 6- and 12-month
Supracrestal tissue dimension
Time Frame: At baseline, 6- and 12-month
Distance from the gingival margin to the alveolar bone crest (GM-ABC) as determined by bone sounding following local anesthesia. Measured in mm.
At baseline, 6- and 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Crown Lengthening RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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