NCT06184607

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

December 14, 2023

Last Update Submit

February 6, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • contact point-attachment level

    A periodontal probe will be used to measure primary outcome measure

    12 months

  • contact point-papilla tip

    A periodontal probe will be used to measure primary outcome measure

    12 months

Study Arms (1)

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

Interventions

A periodontal probe will be used to measure distance between contact point to attachment level in maxillary central incisors

Maxillary anterior interdental papilla

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Dr Sakshi Malhotra, MDS

    PGIDS, Rohtak, Haryana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Sanjay Tewari, MDS

CONTACT

Dr Shikha Tewari, MDS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 28, 2023

Study Start

January 1, 2024

Primary Completion

October 10, 2024

Study Completion

December 15, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations