One- Versus Two-Stage Aesthetic Crown Lengthening

NCT ID: NCT04409366

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-01
• Study Completion Date: 2018-10-01

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional Crown Lengthening (CCL)

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

Two-stage Crown Lengthening (SCL)

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 32997836 (View on PubMed)

Other Identifiers

Crown Lengthening RCT

Identifier Type: -

Identifier Source: org_study_id