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Clinical Trials/NCT03947658
NCT03947658CompletedNot Applicable

Influence of Prosthetic Restorative Treatment Timing on Gingival Margin of Teeth After Surgical Crown Lengthening: a Randomized Controlled Pilot Study.

Aristotle University Of Thessaloniki0 sites18 target enrollmentStarted: January 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Primary Endpoint
Relative gingival margin location change

Study Overview

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.

Detailed Description

Twenty patients selected from those referred to the Department of Periodontics for crown lengthening surgery were enrolled in the study (9 females, 11 males, 19-65 years old, mean age:45.2) Patients were randomly assigned to one of the two experimental groups. For the first group of patients (A), prosthetic restoration started 6 weeks whereas for the second group (B)14 weeks after surgery. After recording of pre-surgical measurements, intrasulcular or internal bevel incisions were performed buccally and lingually, and full-thickness mucoperiosteal flaps were raised. Buccal flaps were reflected to a level beyond the mucogingival junction. The osseous crest and subgingival tooth structure were exposed. The osseous resection was performed after considering the amount of additional tooth structure required for restorative purpose and the preoperative Supracrestal Tissue Attachment at each site with hand and rotary instruments in a manner of establishing positive bone architecture. After root planing, suturing of the surgical sites was performed. The flap margins were placed at or apical to the anticipated crown margin after suturing and as far from the osseous crest as possible and necessary postoperative instructions were given. Patients were recalled 1 week post-surgery for suture removal, oral hygiene reinforcement and healing assessment. Healing was also evaluated at the end of the second post-operative week. All patients were reevaluated at 3 and 6 months after the prosthesis delivery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Arms & Interventions

Six weeks group

Experimental

Prosthetic restoration started 6 weeks after surgical crown lengthening

Intervention: Surgical crown lengthening (Procedure)

Fourteen weeks group

Experimental

Prosthetic restoration started 14 weeks after surgical crown lengthening

Intervention: Surgical crown lengthening (Procedure)

Outcomes

Primary Outcomes

Relative gingival margin location change

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

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

Secondary Outcomes

  • 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)
  • 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)
  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tsachouridou Ioanna

DDS, MSc in Periodontology and Implant Biology, Private practice, Thessaloniki, Greece

Aristotle University Of Thessaloniki

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