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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04219436
Other study ID # PER16-35M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date November 1, 2019

Study information

Verified date January 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 1, 2019
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Altered Passive Eruption of Teeth
  • Exanthema

Intervention

Procedure:
esthetic crown leghthening
two different suturing technique used for flap closure after esthetic crown lengthening

Locations

Country Name City State
Egypt Faculty of Dentistry Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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
6 months
See also
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Completed NCT05512312 - Computer Guided Esthetic Crown Lengthening N/A
Completed NCT03522571 - Experimental Gingivitis in Patients With Altered Passive Eruption N/A