Sutures Clinical Trial - Effect of Different Suture Techniques on Early

Status Not yet recruiting

Clinical Trial Summary

The purposes of this study are to compare the blood perfusion and early healing of horizontal mattress suture with vertical mattress sutures following open-flap implant surgery. Patients wanting single implant replacement in esthetic area will be recruited. This is a randomized, open-label, controlled clinical trial. Noninvasive procedures will be used to assess the primary and secondary outcomes. Inclusion Criteria: With sufficient bone width (≥6mm), With mesial-distal distance over 8mm, age over 18, Willing to participate Exclusion Criteria: Patients want multiple adjacent implant replacements in esthetic area, Untreated periodontitis, Smokers, Diabetes mellitus

Clinical Trial Description

The overall aim of this study is to compare the microcirculation changes of peri-implant soft tissues following open-flap implant surgery using different suture techniques. Subjects fulfilling the inclusion and exclusion criteria will be invited to participate in the study and randomized to one of the two groups: vertical mattress suture (test group) and horizontal mattress suture (control group) on a 1:1 ratio. A laser Doppler flowmetry machine (LDF) (LW1111, LEA) will be used to measure the tissue perfusion. Assessment will be performed at different time, including: Baseline Assessments (presurgical measurements) - T0; Immediate after anesthesia - T1; Immediate after suture - T2; 1 hour after surgery - T3; 2 hours after surgery - T4; 6 hours after surgery - T5; 24 hours after surgery - T6; 72 hours after surgery - T7; 7 days after surgery - T8; 14 days after surgery - T9; 30 days after surgery - T10. The primary outcome is blood perfusion volume (PU) change during the observation period. And secondary outcomes include blood flow velocity change during the observation period, hemoglobin count change during the observation period, blood oxygen saturation change during the observation period; three-dimensional soft-tissue volumetric changes during the observation period, changes in clinical wound healing score during the observation period, PROMs (VAS). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05289635
Study type	Interventional
Source	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact	Junyu Shi, Phd
Phone	02153315299
Email	sakyamuni_jin@163.com
Status	Not yet recruiting
Phase	N/A
Start date	February 1, 2023
Completion date	August 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Different Suture Techniques on Early Healing of Peri-implant Soft Tissue

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms