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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implants; Wound Healing; Sutures
• Intervention / Treatment: Procedure: different suture types

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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junyu Shi, Phd; Phone Number: 02153315299; Email: sakyamuni_jin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18 and above
2. Subjects want single implant treatment in esthetic area (premolar to premolar) in maxilla
3. With sufficient bone width (≥6mm)
4. With mesial-distal distance over 8mm
5. Evidence of subject ability to achieve good oral hygiene and control periodontitis in the whole of the dentition (FMPS<20% and FMBS<20%)
6. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; vertical mattress suture	Procedure: different suture types; 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.
Other: control group; horizontal mattress suture	Procedure: different suture types; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood flow velocity change during the observation period	LEA measurement	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	LEA measurement	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	LEA measurement	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	Intra-oral scanning; the thickness of the soft tissue	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	Clinical measurements and clinical photographs. A modified healing index (Masse 1993); 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); healing tissue consistency and color (l=pink, close-grained; 2=red, soft; 3=gray-green, fragile); 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.	24h after surgery;72h after surgery;7 days after surgery;14days after surgery;30 days after surgery
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.	Immediate after suture;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Chair: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SH9th-03-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No