- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219436
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Dentistry Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: periosteal suturing technique
periosteal suture is done to close the flap
|
two different suturing technique used for flap closure after esthetic crown lengthening
Other Names:
|
ACTIVE_COMPARATOR: figure of eight suturing technique
figure of eight suture is done to close the flap
|
two different suturing technique used for flap closure after esthetic crown lengthening
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of the marginal soft tissue levels rebound
Time Frame: 6 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient aesthetic satisfaction
Time Frame: 6 months
|
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 |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ahmed gamal, professor, Faculty of Dentistry Ain Shams University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PER16-35M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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