- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03947658
Influence of Restorative Timing on Crown Lengthening Outcome.
Influence of Prosthetic Restorative Treatment Timing on Gingival Margin of Teeth After Surgical Crown Lengthening: a Randomized Controlled Pilot Study.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Six weeks group
Prosthetic restoration started 6 weeks after surgical crown lengthening
|
Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation
|
Experimental: Fourteen weeks group
Prosthetic restoration started 14 weeks after surgical crown lengthening
|
Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months after prosthesis delivery (30 to 38 weeks after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pocket depth
Time Frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery,at prosthesis delivery, 3 and 6 months after prosthesis delivery
|
Distance from gingival margin-the base of the pocket in millimeters
|
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
Time Frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
|
Distance from reference stent to the base of the pocket in millimeters
|
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
Time Frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
|
The number of sites presenting with dental plaque appositions
|
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
Time Frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
|
The number of sites presenting with bleeding on probing
|
before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reference stent to the osseous crest before surgery
Time Frame: Before surgery
|
The distance between the reference stent to the osseous crest in millimeters
|
Before surgery
|
Reference stent to the osseous crest after surgery
Time Frame: Immediately after surgery completion
|
The distance from the reference stent to the osseous crest in millimeters
|
Immediately after surgery completion
|
Gingival margin after suturing.
Time Frame: Immediately after surgery completion
|
The distance between the reference stent and the free gingival margin in millimeters
|
Immediately after surgery completion
|
Radiographic change of alveolar crest
Time Frame: 6 months after prosthesis delivery (30 to 38 weeks after surgery)
|
The root apex was used as a reference point and linear measurements from the reference point to the osseous crest of the target-tooth and the adjacent teeth mesially and distally on digital x-rays in millimeters
|
6 months after prosthesis delivery (30 to 38 weeks after surgery)
|
Early wound healing index
Time Frame: At the end of the first and second week after surgery
|
A four-grade soft tissue healing evaluation with the use of Early Healing Index by Wachtel et al 2003. 1 indicates complete flap closure without fibrin line in the interproximal area; 2: complete flap closure with fine fibrin line in the interproximal area;3: complete flap closure with fibrin clot in the interproximal area; 4: incomplete flap closure with partial necrosis of the interproximal tissue 5: incomplete flap closure - complete necrosis of the interproximal tissue
|
At the end of the first and second week after surgery
|
Patient pain and discomfort
Time Frame: End of first week after surgery
|
Questionnaire of 6 questions asking about pain, discomfort and swelling experienced by the patient due to surgery.
The participant responds by choosing an answer from a scale is graded from 1 to 10 with 1 representing the worst and 10 the best answer.
|
End of first week after surgery
|
Patient satisfaction from prosthetic restoration
Time Frame: after the end of prosthetic restoration (8 to 16 weeks after surgery)
|
Questionnaire of 3 questions for the evaluation of patients' satisfaction from the aesthetics and function of the restoration.
The participant responds by choosing an answer from a scale is graded from 1 to 10 with 1 representing the worst and 10 the best answer.
|
after the end of prosthetic restoration (8 to 16 weeks after surgery)
|
Prosthodontist's satisfaction
Time Frame: after the end of prosthetic restoration (8 to 16 weeks after surgery)
|
Questionnaire of 4 questions for the evaluation of prosthodontists' satisfaction from the outcome of the surgical intervention in terms of availability of tooth structure, tooth mobility, bone support adequacy and soft tissue aesthetics.The prosthodontist responds by choosing an answer from a scale is graded from 1 to 10 with 1 representing the worst and 10 the best answer.
|
after the end of prosthetic restoration (8 to 16 weeks after surgery)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 30/03-05-2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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