CTRI Number |
CTRI/2022/11/047354 [Registered on: 16/11/2022] Trial Registered Prospectively |
Last Modified On: |
14/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
correction of gummy smile by invasive and minimally invasive technique |
Scientific Title of Study
|
COMPARATIVE EVALUATION OF OPEN FLAP APPROACH AND MINIMALLY INVASIVE FLAPLESS APPROACH IN AESTHETIC CROWN LENGTHENING BY PIEZOSURGERY – A RANDOMIZED CONTROLLED CLINICAL TRIAL. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Varsha Rani Soni |
Designation |
Post Graduate Student |
Affiliation |
Government Dental College , Raipur |
Address |
Saraf Nursing home, near gausala post office road, Champa Sadar Bazar Champa Janjgir-Champa CHHATTISGARH 495671 India |
Phone |
8889651606 |
Fax |
|
Email |
aanmol.soni@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sangita Agrawal |
Designation |
Reader, Dept of Periodontology |
Affiliation |
Government Dental College , Raipur |
Address |
Government Dental College and Hospital, Raipur
Raipur CHHATTISGARH 492001 India |
Phone |
7999308410 |
Fax |
|
Email |
agsangs@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Varsha Rani Soni |
Designation |
Post Graduate Student |
Affiliation |
Government Dental College , Raipur |
Address |
Saraf Nursing home, near gausala post office road, Champa Sadar Bazar Champa Janjgir-Champa CHHATTISGARH 495671 India |
Phone |
8889651606 |
Fax |
|
Email |
aanmol.soni@gmail.com |
|
Source of Monetary or Material Support
|
Government Dental College, Raipur |
|
Primary Sponsor
|
Name |
Varsha Rani Soni |
Address |
Department of periodontics, Government Dental College, Raipur (C.G.) |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Varsha Rani Soni |
Government Dental College Raipur |
Room no 12 Department of Periodontics, Rajbandha Maidan, Mekahara Chowk ,Raipur Raipur CHHATTISGARH |
8889651606
aanmol.soni@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Government Dental College Raipur (C.G.) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Systemically healthy subjects with gummy smile |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
conventional esthetic crown lengthening |
1. An internal bevel incision will be performed at the desired level of gingival margin after placement of surgical guide.
2. A sulcular incision will be performed to allow gingival tissue removal.
3.A full-thickness mucoperiosteal flap will be reflected to remove and recontour bone tissue by diamond coated tip of piezosurgery unit, until a 3-mm distance between the bone crest and the gingival margin will be achieved.
4. The exposed root surfaces will be carefully planed with curettes.
5. The interrupted sutures will be performed.
follow up at 24 hour, 48 hour, 1week, 6 months
|
Comparator Agent |
minimally invasive flapless esthetic crown lengthening |
1.Internal bevel and sulcular incisions and gingival tissue removal will be performed at the facial aspect of the involved teeth.
2. The osteotomy and osteoplasty will be done using the piezosurgical unit via incisions without flap elevation.
3. The root surfaces will also be carefully planed via incisions.
4. The required distance of 3 mm between the bone crest and the gingival margin will be checked by inserting a periodontal probe into the incision.
5. Sutures will not be performed.
follow up at 24 hour, 48 hour, 1week, 6 months
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Both |
Details |
1.Patients with excessive gingival display due to Altered Passive Eruption (Type 1B) in at least three maxillary teeth (central incisors, lateral incisors, canines, or premolars) per half contralateral quadrant
2.Age more than or equal to 18 years
3.No sites with clinical attachment loss
4. No sites with probing depth >3 mm
5. Systemically healthy subjects.
|
|
ExclusionCriteria |
Details |
ï‚§ Pregnant and lactating women
ï‚§ Habit of tobacco use (smoked and smokeless)
ï‚§ Use of an orthodontic appliance
ï‚§ Previous periodontal surgery in the same area
ï‚§ Prosthesis on treated teeth
ï‚§ Antibiotics or anti-inflammatory therapies during the last three months.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Flapless approach would be showing better clinical results in correcting Altered Passive Eruption when compared to Open Flap approach |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Flapless approach is minimally invasive, with no requirement of suture, this would show better acceptance by the patients |
6 months |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
22/11/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="5" Days="29" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Public esthetic awareness is
centered on an attractive smile, and excess gingival display is a frequent
complaint from patients seeking to improve their appearance. Excessive gingival
display is widespread condition that adversely affects the aesthetic of the
smile.1 The aetiology may be due to skeletal, muscular or
dentogingival abnormalities including elongated maxilla, short and/or
hypertonic maxillary lips, dentoalveolar compensation Angle’s Class II or Class
III occlusion and Altered Passive Eruption (APE). 2
The
most common aetiology is altered passive eruption.3 Goldman &
Cohen (1968), defined altered or retarded passive eruption as a situation in
which the gingival margin in the adult is located incisal to the cervical
convexity of the crown and removed from the cemento–enamel junction of the
tooth.4
Although
the increasing demand for improving aesthetics is becoming an important part of
the current practice of periodontal surgery, the medical literature related to
the treatment of the gingival smile is still insufficient, incoherent, and not
supported by the necessary statistical analysis. There are various
treatment modalities for excessive gingival display which include lip
repositioning, crown lengthening, botulinum toxin-A injections and orthognathic
surgeries. The treatment of choice for altered passive eruption is crown
lengthening.
According
to Glossary of Periodontal terms (2001), crown lengthening is a surgical
procedure devised to increase the extent of supragingival tooth structure for
restorative or esthetic purpose, or combination of both by apically positioning
the gingival margin, removing supporting bone, or both.5 This
procedure reduce the excessive gingival tissue, expose the desirable clinical
crown, and re-establish the appropriate biologic width. Several surgical
techniques were proposed most of them include apically repositioning flap with
osseous surgery or gingivectomy for the treatment of excessive gingival
display. Conventional open flap generally include elevation of full thickness
flap to access and recontour the bone crest to preserve the biologic width. The
disadvantages of this technique are, often time-consuming, may cause pain,
bleeding, post operative morbidity, gingival tissue rebound and require suture.6
The surgical techniques that include flap elevation
cause more coronal displacement of the gingival
margin.7 Therefore, more effective and less invasive treatment
modalities are needed.
The advantages of minimally invasive
techniques are to alleviate post treatment side effects, accelerate healing,
and avoid bone resorption caused by the elevation of full thickness flap.8
The flapless technique is considered to be a promising alternative approach and
is a suture-less, atraumatic, and less
invasive technique that has been shown to increase patient satisfaction and
comfort.1
Piezosurgery is proposed as a minimally
invasive surgical procedure include high precision, a design that increases
ease of curvilinear osteotomy, less trauma to soft tissue, preservation of
neurological and vascular structures, promote neo-osteogenesis, reduced
hemorrhage that improves viability in working area, minimal thermal damage to
the bone, as well as overall improvement of healing.9
The traditional techniques and instruments of
open flap approach have many drawbacks. In this scenario, it is considered
necessary that further research into the different methods for crown
lengthening should be carried out to produce more effective and satisfying
results. Therefore, the purpose of this study is to compare the open flap
approach and minimally invasive flapless approach in aesthetic crown
lengthening for the treatment of altered passive eruption by piezosurgery |