The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability
Primary Purpose
Altered Passive Eruption of Teeth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
esthetic crown leghthening
Sponsored by
About this trial
This is an interventional treatment trial for Altered Passive Eruption of Teeth focused on measuring aesthetic crown lengthening, suturing technique
Eligibility Criteria
Inclusion Criteria:
- Patients complaining from gummy smile (altered passive eruption)
- Bone level is 2 mm or less from the cemento enamel junction
- Teeth included were free from any periodontal destruction
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program
Exclusion Criteria:
- Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).
- Patient suffering from periodontitis stage 4 grade c.
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant females and lactating females. .
- Vulnerable groups of patients (handicapped, mentally retarded, prisoners).
- Restored teeth.
Sites / Locations
- Faculty of Dentistry Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
periosteal suturing technique
figure of eight suturing technique
Arm Description
periosteal suture is done to close the flap
figure of eight suture is done to close the flap
Outcomes
Primary Outcome Measures
evaluation of the marginal soft tissue levels rebound
determination of soft tissue rebound :measuring the amount of attached gingival tissues before and after the surgical procedure by periodontal probe(UNC 15) with reference point in a previously manufactured surgical stent before surgery
Secondary Outcome Measures
patient aesthetic satisfaction
Patient satisfaction criteria (through surveying by a questionnaire)
Prior to surgery
· How would the patient rate the gun shown when smiling, size of the upper teeth, the length of upper teeth and the width of it (way too little, too little, about enough and too much way too much)
After surgery
· Is the patient satisfied with the gingival display during talking and smiling, teeth display during
talking and smiling (not at all, slightly, somewhat, very and extremely).
· How was the procedure experience (much worse, worse, same as I thought, better and much better
Full Information
NCT ID
NCT04219436
First Posted
December 30, 2019
Last Updated
January 4, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04219436
Brief Title
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability
Official Title
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability After Esthetic Crown Lengthening for Treatment of Gummy Smile (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors.
Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width.
Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues.
In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group periosteal suturing technique was done in the second figure of eight (modified interrupted) suturing technique was.
Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery.
The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue.
Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.
Detailed Description
Thirty patients (26 females, 4 males), who were candidates for esthetic crown lengthening, participated in this prospective clinical trial.
Group 1 (15 patients) (Periosteal suture) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then External vertical mattress suture was done (periosteal suture).
Group 2 (15 patients) (Figure of eight suture) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then modified interrupted suture was done (Figure of eight suture).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altered Passive Eruption of Teeth
Keywords
aesthetic crown lengthening, suturing technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arms undergoing the same surgical procedure but with different suturing techniques for flap closure
Masking
ParticipantOutcomes Assessor
Masking Description
The study consisted of two groups the number of patient was determined by sample size calculation through G power analysis (15 patients). Patients were randomly selected using computer generated randomization (www.randomizer.org).
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
periosteal suturing technique
Arm Type
Active Comparator
Arm Description
periosteal suture is done to close the flap
Arm Title
figure of eight suturing technique
Arm Type
Active Comparator
Arm Description
figure of eight suture is done to close the flap
Intervention Type
Procedure
Intervention Name(s)
esthetic crown leghthening
Other Intervention Name(s)
periosteal suture, figure of eight suture
Intervention Description
two different suturing technique used for flap closure after esthetic crown lengthening
Primary Outcome Measure Information:
Title
evaluation of the marginal soft tissue levels rebound
Description
determination of soft tissue rebound :measuring the amount of attached gingival tissues before and after the surgical procedure by periodontal probe(UNC 15) with reference point in a previously manufactured surgical stent before surgery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
patient aesthetic satisfaction
Description
Patient satisfaction criteria (through surveying by a questionnaire)
Prior to surgery
· How would the patient rate the gun shown when smiling, size of the upper teeth, the length of upper teeth and the width of it (way too little, too little, about enough and too much way too much)
After surgery
· Is the patient satisfied with the gingival display during talking and smiling, teeth display during
talking and smiling (not at all, slightly, somewhat, very and extremely).
· How was the procedure experience (much worse, worse, same as I thought, better and much better
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients complaining from gummy smile (altered passive eruption)
Bone level is 2 mm or less from the cemento enamel junction
Teeth included were free from any periodontal destruction
Good compliance with the plaque control instructions following initial therapy.
Availability for follow up and maintenance program
Exclusion Criteria:
Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).
Patient suffering from periodontitis stage 4 grade c.
Presence of smoking habit.
Presence of occlusion interference.
Pregnant females and lactating females. .
Vulnerable groups of patients (handicapped, mentally retarded, prisoners).
Restored teeth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed gamal, professor
Organizational Affiliation
faculty of dentistry ain shams university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
when the study is done the results will be published with the protocol
IPD Sharing Time Frame
the data will be available starting next month and for 1 year
IPD Sharing Access Criteria
the keywords esthetic crown lengthening, suturing techniques in dentistry
Learn more about this trial
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability
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