NCT05351463

Brief Summary

The current prospective, randomized, controlled clinical trial aimed at comparing the impact of papillae suture technique on interdental papilla dimensions after periodontal surgery using a novel 3D intraoral scanning technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

April 14, 2022

Last Update Submit

April 27, 2022

Conditions

Periodontal SurgeryOral Surgery

Outcome Measures

Primary Outcomes (1)

  • papilary volume

    changes in papilary volume using 3D scanner

    12 weeks post surgery

Study Arms (1)

one arm study

OTHER

in each case one site was assigned as control site and one site was assigned as test site.

Procedure: papila suture technique

Interventions

papila suture techniquePROCEDURE

simple interupted vs internal horoizontal matress suture

one arm study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Systemically healthy (based on health questionnaire prior to treatment)
  • Willingness to participate in the study
  • Clinical requirement for periodontal\\ implant surgery

You may not qualify if:

  • Diagnosis of diabetes/heart disease, thrombocytopenia\\ coagulation factors deficiency
  • Chronic use\\abuse of drugs\\ alcohol
  • Pregnancy Smoking more than 10 cigarettes per day Antibiotic consumption in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: RCT parallel study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 28, 2022

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)