| CTRI Number |
CTRI/2019/02/017720 [Registered on: 19/02/2019] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of factors associated with gingival biotypes in adults |
|
Scientific Title of Study
|
Assessment of factors associated with gingival biotypes in adults: a cross-sectional observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailja Naik |
| Designation |
PG student |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of Periodontology,Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
Department of Periodontology, Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
Vadodara
GUJARAT
394601
India |
| Phone |
9409263811 |
| Fax |
|
| Email |
shailja.naik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarath Chandran |
| Designation |
PG guide, HOD |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of Periodontology and Implantology, Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
Department of Periodontology, Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
Vadodara
GUJARAT
394601
India |
| Phone |
9824311676 |
| Fax |
|
| Email |
sarath8@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shailja Naik |
| Designation |
PG student |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of Periodontology, Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
Department of Periodontology, Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
Vadodara
GUJARAT
394601
India |
| Phone |
9409263811 |
| Fax |
|
| Email |
shailja.naik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manubhai Patel Dental College and Hospital,Viswamitri Road, Mauj Mahuda, Vadodara, Gujarat. |
|
|
Primary Sponsor
|
| Name |
Shailja Naik |
| Address |
52/Deepnil Patidar Jin Complex,
Sardar Baug,Station Road,
Bardoli,Dist-Surat,Gujarat
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Periodontics |
Manubhai Patel Dental College and Hospital,Viswajyoti Asharam, Viswamitri Road, Munj Mahuda,Vadodara, Gujarat
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shailja Naik |
Manubhai Patel Dental College and Hospital, Vadodara, Gujarat. |
Department of Periodontology
Vadodara
GUJARAT |
9409263811
shailja.naik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharaja Krishnakumarsinhji Bhavnagar University Ethics Committee for MDS Course and Dental Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy Maxillary Gingiva |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bone sounding. |
The process of probing anaesthetized tissue with a periodontal probe to establish the level of underlying alveolar bone. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects between Age of 18-50 years.
2.Both male and female subjects are included.
3.Intact anterior dentition.(Presence of maxillary anterior teeth)
4.Periodontally Healthy subjects.(subjects with ≤ 10% of sites with bleeding on probing , no pocket depth or CAL > 3 mm)
|
|
| ExclusionCriteria |
| Details |
1.Pregnant female volunteers.
2.Subjects with fillings or crowns in the upper anterior dentition.
3.Tooth crowding (defined as transversal overlapping of the incisal edges >0.5 mm) and abnormal sagittal tooth angulation (incisal edge divergence of >1.5 mm from
a clinically estimated ideal tooth curvature).
4. Intake of any medication affecting the soft tissue health (e.g. amlodipine, cyclosporine A, hydantoin).
5. Volunteers with either sign of periodontal disease defined as periodontal probing depths >3 mm or gingival recessions.
6. Severe smokers (>10 cigarettes/day).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival biotype, gingival thickness, papilla height, gingival width, supracrestal gingival height. |
During OPD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gingival thickness, papilla height, gingival width and supracrestal gingival height |
During OPD |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2019 |
| Date of Study Completion (India) |
11/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The oral gingiva is part of the masticatory
mucosa and is firmly attached to the teeth and underlying bone.
Topographically, the gingiva is divided into three parts: marginal, attached and
interdental gingiva.
There are two different gingival biotypes as
described in the literature: a thick and a thin biotype.An alternative
classification into “very thickâ€, “moderate†and “very thin†biotypes might be
advantageous, because the unique properties are seemingly primarily driven by
subjects with extreme values.
Recently, Substantial scientific interest has
arisen to determine the influence of gingival biotypes on dental therapies. Many
studies focusing on the influence of gingival biotypes on implant treatment
were published.
Consequently, correct assessment of the patients’
gingival biotype is important during treatment planning and crucial prior
periodontal therapy, root coverage procedure and implant treatment in the
aesthetic area.
|