Protocol procedures | Visit 1 | Visit 2 | Visit 2a | Visit 2b | Visit 3 | Visit 4 | Visit 4a | Visit 4b | Visit 4c | Visit 5 | Visit 6 | Visit 7 | Visit 8 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Side I treatment | 1day post-treatment | 5 days post-treatment | Side II treatment | 3 months post- treatment | Surgical treatment | 1 week suture removal | 1 month review | 6 months post- treatment | 9 months post- treatment | 12 months post- treatment | 15 months post- treatment | |
Week 0 | Â | GTI subgroup only | GTI subgroup only | Â | Â | Only subjects in MIST group | Only subjects in MIST group | Only subjects in MIST group | Â | Â | Â | Â | |
Verification inclusion/exclusion, informed consent | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical/dental history & updates Demographics | x | x | x | x | x | x | x | x | x | x | x | x | x |
Height, weight, waist circumference | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
3D facial imaging | x | Â | x | x | Â | x | Â | x | x | Â | x | Â | Â |
Periodontal measurements (PPD, gingival recession, bleeding on probing, mobility and furcation involvement) | x | Â | Â | Â | Â | x | Â | Â | Â | x | x | Â | x |
Plaque assessment | x | Â | Â | Â | Â | x | Â | Â | Â | x | x | x | x |
PROMs | x | Â | x | x | Â | x | Â | x | Â | Â | x | Â | x |
Early healing index | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â |
Standardised X-ray | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | x |
GCF collection | x | Â | x | x | Â | x | Â | Â | Â | Â | x | Â | x |
Subgingival plaque collection/saliva | x | Â | x | x | Â | x | Â | Â | Â | Â | x | Â | x |
Debridement | x | Â | Â | Â | Â | x | Â | Â | Â | x | Â | x | Â |
Impression for radiographic stent | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Dentine/root sensitivity measurements | x | Â | x | x | Â | x | Â | Â | Â | Â | x | Â | x |