Dental Implants, Sutures, Wound Healing
Conditions
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).
Interventions
PROCEDUREdifferent 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.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood perfusion volume (PU) change during the observation period | 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 | LEA measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | LEA measurement |
| 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 | LEA measurement |
| 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 | LEA measurement |
| 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 | 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. |
| patient reported outcome measures (PROMs, VAS) | Immediate after suture;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery; | 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. |
| 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 | Intra-oral scanning; the thickness of the soft tissue |
Contacts
Primary ContactJunyu Shi, Phd
Outcome results
None listed