Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative PurposesNCT04409366
One- Versus Two-Stage Aesthetic Crown Lengthening
A study testing Conventional Crown Lengthening (CCL) and Two-stage Crown Lengthening (SCL) in people with Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes, run by Universidad Complutense de Madrid.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes
- What is being tested?
- Conventional Crown Lengthening (CCL) and Two-stage Crown Lengthening (SCL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 1 Oct 2018
- 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
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes
- Being tested
- Conventional Crown Lengthening (CCL), Two-stage Crown Lengthening (SCL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Crown Lengthening (CCL)Other
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
Two-stage Crown Lengthening (SCL)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Crown Lengthening; CCL | Active comparator | 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. Receives: Other: Conventional Crown Lengthening (CCL) |
| Two-stage Crown Lengthening (SCL) | Experimental | 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 Receives: Other: Two-stage Crown Lengthening (SCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1-T4
The difference in mm between the ideal gingival margin (T1) and the position of the gingival margin at 12 months (T4).
Measured: Baseline-12 months
Secondary outcomes (4)
Clinical Crown Length
Distance from the gingival margin to the incisal edge on the midbuccal.Measured in mm.
Measured: At baseline, 6- and 12-month
Amount of keratinized tissue
Distance from the gingival margin to the mucogingival junction on the midbuccal.Measured in mm.
Measured: At baseline, 6- and 12-month
Gingival display upon smiling
Distance from the gingival margin of the central incisors to the lower edge of the upper lip. Measured in mm.
Measured: At baseline, 6- and 12-month
Supracrestal tissue dimension
Distance from the gingival margin to the alveolar bone crest (GM-ABC) as determined by bone sounding following local anesthesia. Measured in mm.
Measured: At baseline, 6- and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Apr 2013
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative PurposesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409366
- Sponsor's protocol ID
- Crown Lengthening RCT
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Martin O, Carbajo G, Rodrigo M, Montero E, Sanz M. One- versus two-stage crown lengthening surgical procedure for aesthetic restorative purposes: A randomized controlled trial. J Clin Periodontol. 2020 Dec;47(12):1511-1521. doi: 10.1111/jcpe.13375. Epub 2020 Oct 20.
PubMed 32997836
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One- Versus Two-Stage Aesthetic Crown Lengthening for Restorative Purposes: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04409366
- Acronym / sponsor ID
- Crown Lengthening RCT
- Conditions
- Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 1 Jun 2020 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Crown Lengthening; CCL | Active comparator | 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. |
| Two-stage Crown Lengthening (SCL) | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 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 |
| 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) |
Primary outcome
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).
4 secondary outcomes
Clinical Crown Length
Time frame: At baseline, 6- and 12-month
Amount of keratinized tissue
Time frame: At baseline, 6- and 12-month
Gingival display upon smiling
Time frame: At baseline, 6- and 12-month
Supracrestal tissue dimension
Time frame: At baseline, 6- and 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 32997836Gonzalez-Martin O, Carbajo G, Rodrigo M, Montero E, Sanz M. One- versus two-stage crown lengthening surgical procedure for aesthetic restorative purposes: A randomized controlled trial. J Clin Periodontol. 2020 Dec;47(12):1511-1521. doi: 10.1111/jcpe.13375. Epub 2020 Oct 20.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Crown Lengthening (CCL) and Two-stage Crown Lengthening (SCL) in people with Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes, run by Universidad Complutense de Madrid.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
T1-T4 (time frame: Baseline-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409366, which also lists 1 linked publication.
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 1 Jun 2020.