| CTRI Number |
CTRI/2023/11/059519 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving the condition of gums and jaw bone before correction of crooked teeth by wire treatment |
|
Scientific Title of Study
|
Impact Of Phenotype Modification Therapy On Periodontal Health In Patients Undergoing Orthodontic Treatment:
A Randomized Controlled 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 |
Neelima Katti |
| Designation |
Assistant Professor, Department of Periodontics, SCBDCH |
| Affiliation |
SCB Dental College and Hospital, Cuttack |
| Address |
Narayan mishra lane, Mahtab road,Cuttack
Cuttack
ORISSA
753012
India |
| Phone |
09337613446 |
| Fax |
|
| Email |
kattineelima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelima Katti |
| Designation |
Assistant Professor, Department of Periodontics, SCBDCH |
| Affiliation |
SCB Dental College and Hospital, Cuttack |
| Address |
Narayan mishra lane, Mahtab road,Cuttack
Cuttack
ORISSA
753012
India |
| Phone |
09337613446 |
| Fax |
|
| Email |
kattineelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neelima Katti |
| Designation |
Assistant Professor, Department of Periodontics, SCBDCH |
| Affiliation |
SCB Dental College and Hospital, Cuttack |
| Address |
Narayan mishra lane, Mahtab road,Cuttack
Cuttack
ORISSA
753012
India |
| Phone |
09337613446 |
| Fax |
|
| Email |
kattineelima@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Dental College and Hospital, Cuttack |
|
|
Primary Sponsor
|
| Name |
SCB Dental College and Hospital |
| Address |
Mangalabag, Cuttack, odisha |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Neelima Katti |
SCB Dental College and Hospital |
Mangalabag
Cuttack
ORISSA |
9337613446
kattineelima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, SCB Dental College and Hospital, Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Allogenic bone graft and Bioresorbable Collagen membrane placement before orthodontic treatment |
The test group subjects will undergo PhMT using bone graft, and collagen membrane along with coronally advanced flap. The alveolar bone thickness (labial and lingual region) in the mandibular anterior teeth will be measured using Cone-beam computed tomography (CBCT) at baseline (before periodontal surgery) and 6 months post orthodontic treatment. Plaque and gingival index will be scored at baseline, prior to surgery and subsequently at every post-surgical visit during the course of orthodontic treatment. |
| Comparator Agent |
orthodontic treatment only |
The control group will undergo only orthodontic treatment without any phenotype modification by bone graft and collagen membrane. The alveolar bone thickness (labial and lingual region) in the mandibular anterior teeth will be measured using Cone-beam computed tomography (CBCT) at baseline (before periodontal surgery) and 6 months post orthodontic treatment. Plaque and gingival index will be scored at baseline, prior to surgery and subsequently at every post-surgical visit during the course of orthodontic treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with thin gingival biotype, shallow vestibule, presence of fenestration and dehiscence, decreased width of keratinised tissue with ≤2mm gingival recession undergoing orthodontic treatment.
Subjects without any active periodontal disease |
|
| ExclusionCriteria |
| Details |
1. Smoker or tobacco chewing subjects.
2. Pregnant subjects and subjects with systemic diseases or taking drugs which might influence healing after periodontal surgery.
3. Patients with active periodontal disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure and compare width, thickness of keratinised gingiva and bone thickness before and after orthodontic treatment in patients with and without PhMT. |
Baseline, 6 months after surgery, post orthodontic treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque and gingival index,
recession depth and width (if present), probing depth, clinical attachment level, vestibular depth |
Baseline, 6 months after surgery, post orthodontic treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2023 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The relationship between orthodontic tooth movement and the periodontium is dynamic and co-dependent. The mandibular anterior region often presents challenging mucogingival conditions such as reduced vestibular depth, decreased width and thickness of keratinized tissue, and aberrant frenum, presence of fenestration and dehiscences.2 These conditions significantly increase the risk of developing mucogingival problems. In American academy of Periodontology 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions, a new term, periodontal phenotype, was adopted to describe the combination of gingival phenotype (three-dimensional gingival volume) and bone morphotype (thickness of the bone plate).3The periodontal phenotype, plays a crucial role in the development of gingival recessions following orthodontic tooth movement. To mitigate the risk of gingival recession in patients with thin gingival or bone thickness prior to orthodontic treatment, phenotype modification therapy (PhMT) using bone grafts and/or soft tissue grafts has been proposed. The aim is to assess and compare the periodontal status of patients undergoing orthodontic treatment with and without phenotype modification therapy (PhMT). 30 subjects with thin gingival biotype, clinical evidence of fenestration and dehiscence (presence of washboard gingiva) with /without shallow vestibule, decreased width of keratinised tissue, gingival recession undergoing orthodontic treatment will be randomly allotted to test group ( orthodontic treatment post PhMT) and control group ( orthodontic treatment only). The test group subjects will undergo PhMT using bone graft, and/or soft tissue and /or connective tissue graft along with coronally advanced flap. The alveolar bone thickness (labial and lingual region) in the mandibular anterior teeth will be measured using Cone-beam computed tomography (CBCT) at baseline (before periodontal surgery) and 6 months post orthodontic treatment. Plaque and gingival index will be scored at baseline, prior to surgery and subsequently at every post-surgical visit during the course of orthodontic treatment. At each of these visits, gingival width and thickness, recession depth and width (if present), probing depth, clinical attachment level, vestibular depth will also be measured. Supra gingival polishing at each of these visits may be done as required. In addition a healing index for the donor site at 1 week, 2 weeks, 3 weeks, and 4 weeks and an esthetic score for the recipient site at six months post-surgery and post orthodontic treatment will be recorded. |