| CTRI Number |
CTRI/2025/09/095195 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Healing assessment for tooth lengthening procedure to place artificial teeth using two different methods(Rotary burs and piezo surgery) |
|
Scientific Title of Study
|
Assessment of early wound healing following crown lengthening by flap with ostectomy technique using piezo surgery and rotary instruments - A double blinded randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagalakshmi Gandhi |
| Designation |
III year Post Graduate student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No.5, Department of Periodontics, Sri Ramachandra Dental College and hospital,
1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9445842438 |
| Fax |
|
| Email |
nagalakshmidayaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Sabarish |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No. 5, Department of Periodontics, Sri Ramachandra Dental College and hospital,
1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9840549927 |
| Fax |
|
| Email |
ramsabarish@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Sabarish |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No. 5, Department of Periodontics, Sri Ramachandra Dental College and hospital,
1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9840549927 |
| Fax |
|
| Email |
ramsabarish@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Room No. 5, Department of Periodontics, Sri Ramachandra Dental College and hospital,
1, Ramachandra Nagar, Porur, Chennai-600116, India |
|
|
Primary Sponsor
|
| Name |
Dr Nagalakshmi G |
| Address |
Room no.5 Department of periodontics Sri Ramachandra Dental College And Hospital
1 Ramachandra Nagar Porur chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nagalakshmi Gandhi |
Room No. 5, Department of Periodontology |
Sri Ramachandra Dental College and hospital
1 Ramachandra Nagar Porur
Chennai
TAMIL NADU |
09445842438
nagalakshmidayaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy volunteers with dental caries and inadequate teeth height for artificial crown |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crown lengthening using piezo surgery |
crown lengthening procedure with osseous reduction will be done using piezosurgery unit using bur BS4 for the buccal and lingual region and SL2 for the interproximal site with a setting of D2 and 70 ml/min for irrigation for the intervention group.
|
| Comparator Agent |
Crown lengthening using Rotary burs |
crown lengthening procedure with osseous reduction will be done using micromotor with the rotary bur (HP-8) for the comparator group.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy volunteers with inadequate clinical crown height for retention of restoration |
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease and deep sub-gingivally located carious lesions, crown and root fractures, and pre-existing deep preparation margins and with poor oral hygiene, smoking habit, and pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early wound healing |
Third and seventh day post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quantification of Wound fluid using periotron 8000
overall patient satisfaction using the visual analog scale |
Third and seventh day post surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Maintaining healthy gums is essential for successful dental work. Issues such as deep cavities or fractured crowns can compromise gum health by disrupting the attachment between gums and bone, potentially leading to gum swelling, tissue loss, and bone damage. Therefore, understanding the interplay between dental work and gum health is crucial for effective treatment planning and achieving favorable outcomes. Crown lengthening is a technique used to address these problems by providing adequate space for a secure attachment between the bone and the crown. This procedure can be performed using various methods, including gum tissue removal or bone reshaping. While bone reshaping can be accomplished with specialized instruments, these may generate heat, which can impede healing. Piezosurgery offers an alternative approach that utilizes sound waves to precisely cut bone without causing thermal damage, potentially reducing post-operative complications. The healing process following bone reshaping has been evaluated, considering factors like crown height and gum contour. However, there is limited research on the efficacy of piezosurgery in crown lengthening. This study aims to compare the healing outcomes of crown lengthening performed with conventional instruments versus piezosurgery. |