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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06184607
Other study ID # Sakshi Perio
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 15, 2024

Study information

Verified date February 2024
Source Postgraduate Institute of Dental Sciences Rohtak
Contact Dr Sanjay Tewari, MDS
Phone 9416459534
Email principalpgids@yahoo.in
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 195
Est. completion date December 15, 2024
Est. primary completion date October 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
India Post Graduate Institute of Dental Sciences Rohtak Haryana

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary contact point-attachment level A periodontal probe will be used to measure primary outcome measure 12 months
Primary contact point-papilla tip A periodontal probe will be used to measure primary outcome measure 12 months
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