Clinical trial NCT05289635: Effect of Different Suture Techniques on Early Healing of Peri-implant Soft Tissue
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implants
Wound Healing
Sutures
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Blood perfusion volume (PU) change during the observation period
timeFrame: 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:
measure: Blood flow velocity change during the observation period
timeFrame: 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
measure: Hemoglobin count change during the observation period
timeFrame: 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
measure: Blood oxygen saturation change during the observation period
timeFrame: 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
measure: Three-dimensional soft-tissue volumetric changes during the observation period
timeFrame: 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
measure: Changes in clinical wound healing score during the observation period
timeFrame: 24h after surgery;72h after surgery;7 days after surgery;14days after surgery;30 days after surgery
measure: patient reported outcome measures (PROMs, VAS)
timeFrame: Immediate after suture;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Maurizio S. Tonetti, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.