NCT05289635

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

March 6, 2022

Last Update Submit

January 13, 2023

Conditions

Dental ImplantsWound HealingSutures

Outcome Measures

Primary Outcomes (1)

  • Blood perfusion volume (PU) change during the observation period

    LEA measurement

    Immediate after anesthesia;Immediate after suture;1hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7days after surgery;14ddays after surgery;30days after surgery

Secondary Outcomes (6)

  • Blood flow velocity change during the observation period

    Immediate after anesthesia;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30days after surgery

  • Hemoglobin count change during the observation period

    Immediate after anesthesia;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30days after surgery

  • Blood oxygen saturation change during the observation period

    Immediate after anesthesia;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30days after surgery

  • Three-dimensional soft-tissue volumetric changes during the observation period

    1. Intra-oral scanning: before surgery;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30 day after surgery

  • Changes in clinical wound healing score during the observation period

    24h after surgery;72h after surgery;7 days after surgery;14days after surgery;30 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

test group

EXPERIMENTAL

vertical mattress suture

Procedure: different suture types

control group

OTHER

horizontal mattress suture

Procedure: different suture types

Interventions

different suture typesPROCEDURE

For a wound that is deeper in nature, a mattress stitch can be placed, providing better strength. Mattress sutures can be applied as vertical or horizontal subtypes. So far, various studies have compared the effect of horizontal mattress suture (HMS) with vertical mattress suture (VMS) on wound healing in different wound. However, limited studies have evaluated the effect of the subtype of mattress sutures on the early wound healing and microcirculation changes of peri-implant soft tissues following implant surgery using Laser Doppler flowmetry. The test group use vertical mattress suture and the control group use the horizontal mattress suture.

control grouptest group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 and above
  • Subjects want single implant treatment in esthetic area (premolar to premolar) in maxilla
  • With sufficient bone width (≥6mm)
  • With mesial-distal distance over 8mm
  • Evidence of subject ability to achieve good oral hygiene and control periodontitis in the whole of the dentition (FMPS\<20% and FMBS\<20%)
  • Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give written informed consent.

You may not qualify if:

  • Subjects want multiple adjacent implant treatment
  • Patients with inadequate bone volume where major bone augmentation would be required at implant location.
  • Subjects with untreated periodontitis
  • Current smokers
  • Subjects with diabetes mellitus.
  • Pregnant females
  • Participation in another intervention trial
  • Inability or unwillingness of individual to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Marsidi N, Vermeulen SAM, Horeman T, Genders RE. Measuring Forces in Suture Techniques for Wound Closure. J Surg Res. 2020 Nov;255:135-143. doi: 10.1016/j.jss.2020.05.033. Epub 2020 Jun 16.

    PMID: 32543379RESULT

  • Montanez A, Makarewich CA, Burks RT, Henninger HB. The Medial Stitch in Transosseous-Equivalent Rotator Cuff Repair: Vertical or Horizontal Mattress? Am J Sports Med. 2016 Sep;44(9):2225-30. doi: 10.1177/0363546516648680. Epub 2016 Jun 8.

    PMID: 27281277RESULT

  • Maemura K, Mataki Y, Kurahara H, Tanoue K, Kawasaki Y, Ijichi T, Iino S, Ueno S, Shinchi H, Natsugoe S. The 1-year outcomes after pancreaticogastrostomy using vertical versus horizontal mattress suturing for gastric wrapping. Surg Today. 2021 Apr;51(4):511-519. doi: 10.1007/s00595-020-02134-z. Epub 2020 Sep 23.

    PMID: 32968859RESULT

  • Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.

    PMID: 12795787RESULT

  • Burkhardt R, Lang NP. Role of flap tension in primary wound closure of mucoperiosteal flaps: a prospective cohort study. Clin Oral Implants Res. 2010 Jan;21(1):50-4. doi: 10.1111/j.1600-0501.2009.01829.x.

    PMID: 20070747RESULT

Study Officials

  • Maurizio S. Tonetti, Professor

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    STUDY CHAIR

Central Study Contacts

Junyu Shi, Phd

CONTACT

02153315299sakyamuni_jin@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 6, 2022

First Posted

March 21, 2022

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share