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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Maxillary anterior interdental papilla
Presence or loss of interdental papilla with intact maxillary central incisors in systemically healthy patients
Other: Distance from contact point to attachment level
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Dental Sciences Rohtak

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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