NCT03947658

Brief Summary

Setting the restorative margins for teeth with short clinical crowns is challenging and crown lengthening surgery (CLS) is often necessary. The aim of this study was to assess the influence of prosthetic restorative treatment timing on gingival margin location of teeth after crown lengthening surgery. Eighteen patients requiring CLS were enrolled in the study and divided into two groups depending on the timing of prosthetic rehabilitation, at 6 or fourteen weeks after CLS.Clinical parameters were recorded around treated and neighboring teeth with adjacent and non-adjacent sites at 6 and 14 weeks after surgery as well as three and six months after prosthesis delivery. Alveolar ridge changes were assessed via digital X-rays.Soft tissue healing and the final treatment outcome were assessed by both patients and prosthodontists.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

May 8, 2019

Last Update Submit

May 9, 2019

Conditions

Crown Lengthening

Keywords

surgicalprosthetic restorationgingivasurgical flapsstents

Outcome Measures

Primary Outcomes (1)

  • Relative gingival margin location change

    The relative position of free gingival margin as measured from an individualized reference stent in millimeters

    6 months after prosthesis delivery (30 to 38 weeks after surgery)

Secondary Outcomes (4)

  • Pocket depth

    before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery,at prosthesis delivery, 3 and 6 months after prosthesis delivery

  • Relative clinical attachment loss

    before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery

  • Plaque index

    before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery

  • Gingival bleeding index

    before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery

Other Outcomes (8)

  • Reference stent to the osseous crest before surgery

    Before surgery

  • Reference stent to the osseous crest after surgery

    Immediately after surgery completion

  • Gingival margin after suturing.

    Immediately after surgery completion

  • +5 more other outcomes

Study Arms (2)

Six weeks group

EXPERIMENTAL

Prosthetic restoration started 6 weeks after surgical crown lengthening

Procedure: Surgical crown lengthening

Fourteen weeks group

EXPERIMENTAL

Prosthetic restoration started 14 weeks after surgical crown lengthening

Procedure: Surgical crown lengthening

Interventions

Surgical crown lengtheningPROCEDURE

Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation

Fourteen weeks groupSix weeks group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years,
  • periodontally healthy or periodontally treated subjects with Plaque scores ≤15% \& GI ≤15%
  • each patient could participate with one tooth only,
  • non-smokers or smokers of less than 5 cigarettes per day,
  • target tooth should be surrounded by both the adjacent teeth which should not be restored,
  • provisional and final prosthetic margins should not extend subgingivally,
  • in case of fracture this should be radiographically detectable,
  • if a root canal treatment was necessary it should have been completed at least 6 months earlier.
  • both anterior and posterior teeth included.

You may not qualify if:

  • the presence of syndromes affecting bone metabolism,
  • any kind of contraindication for periodontal surgery,
  • pregnancy or lactation,
  • no compliance with re-examinations or oral hygiene performance
  • cases where gingivectomy or apically repositioned flap without osseous resection were indicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Malamoudi GA, Tsachouridou I, Menexes G, Mikrogeorgis G, Tortopidis D, Tsalikis L. Pre-restorative crown lengthening surgery: influence of restorative treatment timing on clinical outcomes-a pilot study. Oral Maxillofac Surg. 2024 Mar;28(1):253-267. doi: 10.1007/s10006-023-01138-6. Epub 2023 Jan 25.

    PMID: 36695965DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MSc in Periodontology and Implant Biology, Private practice, Thessaloniki, Greece

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 13, 2019

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

May 13, 2019

Record last verified: 2019-05