| CTRI Number |
CTRI/2026/02/103784 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECTS ON GUMS DUE TO TREATMENT WITH FIXED BITE BLOCKS ON UPPER FRONT TEETH IN BRACES TREATMENT A PROSPECTIVE STUDY |
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Scientific Title of Study
|
PERIODONTAL CHANGES ASSOCIATED WITH FIXED ANTERIOR BITE TURBOS IN MAXILLARY CENTRAL INCISORS IN ORTHODONTIC PATIENTS: A
PROSPECTIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay Kumar Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number 210, OPD block-2nd floor, Department of Dentistry, Basni-2 AIIMS
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
drvinaychd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number 210, OPD block-2nd floor, Department of Dentistry, Basni-2 AIIMS
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
drvinaychd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vayshnavi V |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number 210, OPD block-2nd floor, Department of Dentistry, Basni-2 AIIMS
Jodhpur
Rajasthan
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09645471827 |
| Fax |
|
| Email |
vayshnavivanand98@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Pin: 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
AIIMS Jodhpur,Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Kumar Chugh |
All India Institute of Medical Sciences, Jodhpur |
Room number-210, OPD block-2nd floor, Department of Dentistry, Basni-2 AIIMS Jodhpur Rajasthan
342005
India
Jodhpur
RAJASTHAN |
8003996704
drvinaychd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute of Medical Sciences, Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Orthodontic treatment with placement of anterior bite turbo |
Periodontal changes and success rate associated with
the placement of anterior bite turbos in the maxillary central incisor in patients undergoing fixed orthodontic treatment will be assessed using plaque index, periodontal pocket depth, bleeding on
probing, and gingival enlargement measurements taken at four intervals; T0 (prior to placement of anterior bite turbos), T1 (6 weeks), T2 (3 months), T3 (6 months) and T4 (12 months).
Patients will receive a full mouth scaling and prophylaxis 1 week prior to the bonding, and dental hygiene
instructions on the day of fixed orthodontic appliance placement. Sequential banding and bonding will be done using MBT prescription (0.022 x 0.028-inch slot). A baseline periodontal evaluation (T0) such as the plaque index (PI),
probing pocket depth (PPD), bleeding on probing (BOP), will be measured at the labial, palatal, mesial and
distal sites and gingival enlargement (GE) at labial and palatal sides of maxillary central incisors prior to placement of anterior bite turbos. Anterior bite turbo will be fabricated using nanohybrid composite. The composite will be placed into a mini-mold tip to obtain uniform dimensions and shape for all turbos. The anterior bite turbos will be bonded on middle third of palatal surface of maxillary central
incisors. After placement, occlusion will be checked to confirm that the anterior bite turbos provided proper
disocclusion of the posterior teeth, preventing any premature contacts. Periodontal evaluations will be repeated at 6 weeks (T1), 3 months (T2), 6 months (T3) and 12 months (T4) after placement of anterior bite turbos. Success rate of anterior bite turbos will be considered successful when both the bite turbos remained intact over the 12 months study period. |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients belonging to the age group of 16-35 years belonging to both sexes.
2) Patient requiring the need for placement of anterior bite turbo for at least duration of 12 months during fixed orthodontic treatment.
3) Good oral hygiene.
4) No history of any systemic diseases.
5) No pharmacological treatment or antibiotic therapy during or up to 4 months before the study which may affect the gingival tissues.
6) No enlargement of incisive papilla or high frenal attachment in relation to central incisors.
|
|
| ExclusionCriteria |
| Details |
1) Patients with history of missing maxillary central incisors.
2) Patients with history of smoking.
3) Pregnant women.
4) Patient with pocket depth of 4 mm with radiographic bone loss.
5) Patients having extensive dental restorations (such as crowns or bridges) in relation to maxillary central incisors.
6) Patients having plaque stagnation areas ( such as removable partial dentures) in relation to maxillary central incisors .
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the quantitative changes in plaque accumulation (using Sillness and Löe Plaque Index) around the maxillary central incisors with anterior bite turbos taken at four intervals - T0, T1, T2, T3 AND T4 to identify the changes in periodontium and oral hygiene status. |
T0-baseline (Before the placement of anterior anterior bite turbo)
T1 (6 weeks) after the placement of anterior bite turbo,
T2 (3 months) after the placement of anterior bite turbo,
T3 (6 months) after the placement of anterior bite turbo, and
T4 (12 months) after the placement of anterior bite turbo. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate changes in probing pocket depth around the maxillary central incisors with anterior bite turbo from T0 to T4 to detect changes in periodontal pocket depth.
2.To examine bleeding on probing from T0 to T4 to detect gingival inflammatory response due to plaque retention.
3.To evaluate gingival enlargement from T0 to T4 to detect chronic inflammatory adaptation caused by anterior bite turbo
4.Determination of success rate of anterior bite turbos, including assessment of debonding, fracture, or need for replacement.
|
T0-baseline(Before the placement of anterior anterior bite turbo)
T1-6 weeks after the placement of anterior bite turbo
T2-3 months after the placement of anterior bite turbo
T3-6 months after the placement of anterior bite turbo
T4-12 months after the placement of anterior bite turbo |
|
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Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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 4 |
|
Date of First Enrollment (India)
|
23/02/2026 |
| 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="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
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
|
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Brief Summary
|
Malocclusion correction using anterior bite turbos is a common orthodontic practice. This prospective study aims to evaluate the periodontal changes and success rate associated with the placement of anterior bite turbos in the maxillary central incisor in patients undergoing fixed orthodontic treatment by assessing plaque index, periodontal pocket depth, bleeding on probing, and gingival enlargement over time since their influence on periodontal health remains underexplored. Population- Orthodontic patients aged 16–35 years requiring anterior bite turbos as part of their fixed orthodontic treatment Intervention – Placement of anterior bite turbos on maxillary central incisors. Comparator – Same group pre-treatment periodontal parameters (baseline) compared with follow-up measurements at 6 weeks, 3 months, 6 months and 12 months. Outcomes - Changes in plaque index, periodontal pocket depth, bleeding on probing, and gingival enlargement. Time period- 12 months |