Attachment Loss, PeriodontalNCT06184607
Relationship Between Contact Point to Attachment Level and Presence of Interdental Papilla
An observational study of Attachment Loss, Periodontal, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Attachment Loss, Periodontal
- What is being tested?
- Distance from contact point to attachment level
- How many people
- 195 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2024to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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%
Who cannot join
- • 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
Show all 11Show fewer
- Trauma from occlusion
- Crowding or spacing in maxillary central incisors
- Angular bone defects
- Pregnant women
- Mobile tooth
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Shikha Tewari, MDS
About this study
Official title: 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.
Read the 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.
- Conditions
- Attachment Loss, Periodontal
- Being tested
- Distance from contact point to attachment level
- Medical subject headings
- Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance from contact point to attachment levelOther
A periodontal probe will be used to measure distance between contact point to attachment level in maxillary central incisors
| Study group | Role | What they receive |
|---|---|---|
| Maxillary anterior interdental papilla | Presence or loss of interdental papilla with intact maxillary central incisors in systemically healthy patients Receives: Other: Distance from contact point to attachment level |
What is being measured
The primary outcome is the main question the study is designed to answer.
contact point-attachment level
A periodontal probe will be used to measure primary outcome measure
Measured: 12 months
contact point-papilla tip
A periodontal probe will be used to measure primary outcome measure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jan 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attachment Loss, PeriodontalStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Sakshi Malhotra, MDS, Principal investigator, PGIDS, Rohtak, Haryana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184607
- Sponsor's protocol ID
- Sakshi Perio
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Distance Between Contact Point to Attachment Level With the Presence of Interdental Papilla in Maxillary Central Incisors: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06184607
- Acronym / sponsor ID
- Sakshi Perio
- Conditions
- Attachment Loss, Periodontal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxillary anterior interdental papilla | – | Other: Distance from contact point to attachment levelPresence or loss of interdental papilla with intact maxillary central incisors in systemically healthy patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Intact maxillary central incisors
- Age 18-50 years
- Closed contact points
- No history of traumatic tooth injury
- Completion of cause related therapy before 3months
Key exclusion criteria (11 listed)
- • Systemic ailments which affect periodontium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distance from contact point to attachment levelA periodontal probe will be used to measure distance between contact point to attachment level in maxillary central incisors | Other | Maxillary anterior interdental papilla |
Primary outcome
contact point-attachment level
Time frame: 12 months
A periodontal probe will be used to measure primary outcome measure
contact point-papilla tip
Time frame: 12 months
A periodontal probe will be used to measure primary outcome measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Sakshi Malhotra, MDS principal investigator
PGIDS, Rohtak, Haryana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attachment Loss, Periodontal, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Sanjay Tewari, MDS (9416459534 ext. 91, principalpgids@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contact point-attachment level (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.