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Dental ImplantsNCT05289635

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

A study testing different suture types in people with Dental Implants and Wound Healing, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dental Implants, Wound Healing, Sutures
What is being tested?
different suture types
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Feb 2023to 1 Aug 2023
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Junyu Shi, Phd contact

02153315299

sakyamuni_jin@163.com

About this study

Official title: Effect of Different Suture Techniques on Early Healing of Peri-implant Soft Tissue Following Open-flap Implant Surgery in Esthetic Area: a Randomized Clinical Trial Comparing Horizontal and Vertical Mattress Sutures

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

Read the detailed 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).

Being tested
different suture types

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • different suture typesProcedure or surgery

    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.

Study groups in NCT05289635
Study groupRoleWhat they receive
test groupExperimentalvertical mattress suture
Receives: Procedure: different suture types
control groupOtherhorizontal mattress suture
Receives: Procedure: different suture types

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood perfusion volume (PU) change during the observation period

    LEA measurement

    Measured: 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)

  1. Blood flow velocity change during the observation period

    LEA measurement

    Measured: 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

  2. Hemoglobin count change during the observation period

    LEA measurement

    Measured: 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

  3. Blood oxygen saturation change during the observation period

    LEA measurement

    Measured: 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

  4. Three-dimensional soft-tissue volumetric changes during the observation period

    Intra-oral scanning; the thickness of the soft tissue

    Measured: 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

  5. Changes in clinical wound healing score during the observation period

    Clinical measurements and clinical photographs. A modified healing index (Masse 1993)

    1. tissue color (1 = the gingival tissue was entirely pink; 2 = less than half of the gingival tissue was red, movable, and hyperemic;3 = more than half of the gingival tissue was red, movable, and hyperemic)
    2. healing tissue consistency and color (l=pink, close-grained; 2=red, soft; 3=gray-green, fragile)
    3. bleeding (l= none; 2=only upon palpation; 3=spontaneous) suppuration (1= none; 2=none, but significant amounts of plaque around the walls of the socket; 3=suppuration.

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

  6. patient reported outcome measures (PROMs, VAS)

    A horizontal line about 10 cm long was used, with "0" and "10" ends at each end, with 0 being no pain and 10 being the most severe pain that was unbearable.

    Visual analogue scale (0-10) will be used to evaluate the post-operative pain.

    Measured: Immediate after suture;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start1 Feb 2023 (estimated)
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05289635
Sponsor's protocol ID
SH9th-03-07
Status last verified
Jan 2023
First submitted
6 Mar 2022
Last updated
17 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32543379

  • 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.

    PubMed 27281277

  • 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.

    PubMed 32968859

  • 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.

    PubMed 12795787

  • 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.

    PubMed 20070747

Questions about this trial

What is this clinical trial studying?

A study testing different suture types in people with Dental Implants and Wound Healing, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.

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 8 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 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

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 Junyu Shi, Phd (02153315299, sakyamuni_jin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood perfusion volume (PU) change during the observation period (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05289635, which also lists 5 linked publications.

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 17 Jan 2023.

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