FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Close