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Clinical Trials/NCT05351463
NCT05351463CompletedNot Applicable

Papilla Suture Design Affects Papillary Postsurgical Dimensions

Hadassah Medical Organization1 site in 1 country20 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
papilary volume

Study Overview

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.

Detailed Description

Scientific rationale for study: Choosing the appropriate suture design for periodontal surgery may affect post-surgery tissue dimension. This is a critical issue in periodontal surgery due to the grave impact papilla play on soft tissue esthetics.

Principal findings: using the novel 3D scanning of the gingiva tissue show that simple interrupted suture negatively affect post-surgery papillary height and recession adjacent to the suture compared with vertical internal mattress suture.

Practical implications: the study provide evidence that allows the clinician to better choose the suture design that will allow optimal healing of the papilla. Furthermore, the study presents a novel 3D scanning method to analyzed dimensional changes in the soft tissue.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

papilary volume

Time Frame: 12 weeks post surgery

changes in papilary volume using 3D scanner

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Polak David

Principal Investigator

Hadassah Medical Organization

Study Sites (1)

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