- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06184607
Relationship Between Contact Point to Attachment Level and Presence of Interdental Papilla
February 6, 2024 updated by: Postgraduate Institute of Dental Sciences Rohtak
Relationship of Distance Between Contact Point to Attachment Level With the Presence of Interdental Papilla in Maxillary Central Incisors: A Cross-sectional Study
Thorough search of literature revealed no study has correlated the presence/absence of papilla to the contact point to attachment level distance.
It could be a non- invasive approach and there is no need to inject local anaesthesia to the patient.
It might be beneficial in predicting the papilla reconstruction outcome in patient friendly and non-invasive way.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The presence of interdental papilla specially of maxillary anterior tooth region is an essential esthetic component.
Loss of papilla or black triangle is not appealing and it is concern for both patient and clinicians.
Beside esthetic concern, black triangle is associated with phonetic problem and food impaction.
Several factors which may influence the presence/absence of interdental papilla are alveolar bone height, gingival biotype, interdental space morphology, type of contact area.
Different classification system to categorize interdental papilla loss have been proposed.
In the landmark study by Tarnow, a correlation was found between vertical distance from contact point to bone crest and presence/ absence of interdental papilla.
Interdental clinical attachment level may indirectly indicate the changes in underlying bone level and it has been proven to be an important prognostic factor in consideration of success of root coverage procedure.
Thorough search of literature revealed no study has correlated the presence/absence of papilla to the contact point to attachment level distance.
It could be a non- invasive approach and there is no need to inject local anaesthesia to the patient.
It might be beneficial in predicting the papilla reconstruction outcome in patient friendly and non-invasive way.
Study Type
Observational
Enrollment (Estimated)
195
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dr Sanjay Tewari, MDS
- Phone Number: 91 9416459534
- Email: principalpgids@yahoo.in
Study Contact Backup
- Name: Dr Shikha Tewari, MDS
- Phone Number: 91 9416514600
- Email: drshikhatewari@yahoo.com
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Recruiting
- Post Graduate Institute of dental sciences
-
Contact:
- Shikha Tewari, MDS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Systemically healthy patients with intact maxillary central incisors will be recruited from the outpatient department of Periodontics and Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.
Description
Inclusion Criteria:
- Intact maxillary central incisors
- Age 18-50 years
- Closed contact points
- No history of traumatic tooth injury
- Completion of cause related therapy before 3months
- Full mouth plaque score and full mouth bleeding score <15%
Exclusion Criteria:
• Systemic ailments which affect periodontium
- History of previous periodontal surgery
- Tooth with a prosthetic crown or restoration involving cementoenamel junction (CEJ).
- Pathologic tooth migration
- Presence of cervical abrasion/erosions
- Presence of dental caries in maxillary central incisors
- Trauma from occlusion
- Crowding or spacing in maxillary central incisors
- Angular bone defects
- Pregnant women
- Mobile tooth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Maxillary anterior interdental papilla
Presence or loss of interdental papilla with intact maxillary central incisors in systemically healthy patients
|
A periodontal probe will be used to measure distance between contact point to attachment level in maxillary central incisors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
contact point-attachment level
Time Frame: 12 months
|
A periodontal probe will be used to measure primary outcome measure
|
12 months
|
|
contact point-papilla tip
Time Frame: 12 months
|
A periodontal probe will be used to measure primary outcome measure
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr Sakshi Malhotra, MDS, PGIDS, Rohtak, Haryana
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
October 10, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
December 14, 2023
First Submitted That Met QC Criteria
December 14, 2023
First Posted (Actual)
December 28, 2023
Study Record Updates
Last Update Posted (Estimated)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sakshi Perio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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