Study population
A total of 20 patients (8 males/12 females) aged 46.4±14.7 years were recruited and 19 completed all study procedures. One female PAL group patient withdrew before T2, due to relocating. Data from all patients are reported. There were no significant differences regarding age, gender, implant location and flap thickness between groups (Table I), even with removal of the one subject. Implant diameter was significantly different as the 4 out of the 10 patients in the PAL group received narrower diameter implants (3.3mm), while all patients in the TUB group received standard diameter implants (4.1mm) (Table I).
Table I. Population characteristics
Characteristics
|
PAL
|
TUB
|
Total
|
p-value
|
N
|
10
|
10
|
20
|
|
Gender
|
Males
|
5
|
3
|
8
|
0.1†
|
Females
|
5
|
7
|
12
|
Age (mean±SD)
|
48.9±14.5
|
44.0±14.2
|
46.5±14.7
|
0.5‡
|
Location
|
Maxilla
|
8
|
6
|
14
|
0.1†
|
Mandible
|
2
|
4
|
6
|
Lateral incisor
|
1
|
0
|
1
|
|
Canine
|
1
|
0
|
1
|
|
First premolar
|
4
|
3
|
7
|
|
Second premolar
|
4
|
7
|
11
|
|
Implant diameter (mm)
|
4.1
|
6
|
10
|
16
|
0.03†
|
3.3
|
4
|
0
|
4
|
Flap thickness (mm, mean±SD)
|
1.2±0.5
|
1.3±0.6
|
|
0.7‡
|
Drop-outs
|
1*
|
0
|
1
|
|
PAL, palatal graft group; TUB, tuberosity graft group; N, number of participants; SD, standard deviation.
† Chi-square test, boldface indicates statistical significance.
‡ Independent sample T-test
*Patient dropped out between T1 and T2
STT changes
STT changes are detailed in Table II. For both groups, STT changes differed significantly by time (p<0.002) and by level (p=0.000). The greatest STT changes were observed between T0 and T2, and the smallest between T1 and T2. STT change magnitude decreased from the most coronal (A0) to the most apical tissue levels (Aiv). However, no significant STT change differences were observed between groups, at any level or time point (Supplemental Table I).
Table II. Soft tissue thickness changes (mm) over time, at different apico-coronal levels.
Levels
|
Groups
|
T1-T0
|
T2-T0
|
T2-T1
|
At-level
group effect
(p-value) †
|
At-level
time effect
(p-value) †
|
A0
|
PAL
|
1.7±1.4
|
2.2±1.2
|
0.4±0.7
|
0.503
|
0.001
|
TUB
|
1.9±1.1
|
2.5±1.3
|
0.6±0.4
|
Ai
|
PAL
|
1±1
|
1.4±0.8
|
0.4±1.2
|
0.244
|
0.002
|
TUB
|
1.4±1
|
1.9±1.1
|
0.5±0.6
|
Aii
|
PAL
|
1±0.4
|
1.1±0.6
|
0±0.7
|
0.111
|
0.000
|
TUB
|
1.2±0.9
|
1.6±1.2
|
0.4±0.6
|
Aiii
|
PAL
|
0.9±0.2
|
0.9±0.5
|
0±0.6
|
0.894
|
0.000
|
TUB
|
0.8±0.7
|
0.9±0.9
|
0.1±0.5
|
Aiv
|
PAL
|
0.7±0.2
|
0.6±0.7
|
-0.1±0.8
|
0.886
|
0.001
|
TUB
|
0.6±0.6
|
0.6±0.6
|
0.1±0.3
|
Values reported are mean±SD. Data from nPAL= nTUB=10, except for T2 where nPAL=9.
SD, standard deviation; PAL, palatal graft group; TUB, tuberosity graft group.
Time points: T0, baseline; T1, 2 months postoperatively; T2, 12 months postoperatively.
T1-T0, change between T0 and T1; T2-T0, change between T0 and T2; T2-T1, change between T1 and T2.
Levels: A0, level of adjacent CEJs; Ai, 1mm apical to A0; Aii, 2mm apical to A0; Aiii, 3mm apical to A0; Aiv, 4mm apical to A0.
† Repeated measures ANOVA, Tukey’s test; boldface indicates statistical significance.
MBL changes
MBL changes are detailed in Table III. For both groups, time significantly affected MBL changes (p=0.008). The greatest MBL change was observed between IP and T2 and the smallest between T1 and T2, for both groups. However, no significant intergroup differences in MBL changes were found during any time period.
Table III. Marginal bone loss (mm) over time.
|
T1-IP
|
T2-IP
|
T2-T1
|
Group effect
(p-value) ‡
|
Time effect
(p-value) ‡
|
Group:Time effect
(p-value) ‡
|
PAL
|
0.9±0.7
|
1.3±0.9
|
0.4±0.5
|
0.194
|
0.008
|
0.481
|
TUB
|
0.5±0.4
|
1±0.8
|
0.5±0.6
|
p-value†
|
0.142
|
0.376
|
0.786
|
|
|
|
Values reported are mean±SD. Data from nPAL= nTUB=10, except for T2 where nPAL=9.
SD, standard deviation; PAL, palatal graft group; TUB, tuberosity graft group; IP, time of implant placement; T1: 2 months postoperatively; T2: 12 months postoperatively.
† Independent-samples Mann-Whitney U test
‡ Multivariate analysis of variance; boldface indicates statistical significance (p<0.05).
Pain outcomes
Pain outcomes are detailed in Table IV. For both groups, and for both RS and DS, time had a significant effect (p≤0.014), with mean pain scores significantly reduced from W1 to W2. Group had a significant effect only for DS (p=0.010), with mean pain scores significantly lower for TUB at W1 (p=0.023).
Table IV. VAS pain scores for recipient and donor sites over time
|
Recipient site pain score
|
Donor Site pain score
|
|
W1
|
W2
|
W1
|
W2
|
PAL
|
3.2±2.5
|
1.6±2.4
|
3.9±3.2*
|
1.5±2.4
|
TUB
|
1.5±1.3
|
0.4±0.5
|
1.3±1*
|
0.4±0.5
|
Group effect
(p-value) †
|
0.108
|
0.010
|
Time effect
(p-value) †
|
0.014
|
0.002
|
Group:Time effect
(p-value) †
|
0.390
|
0.675
|
Values reported are mean±SD. Data from nPAL= nTUB=10
VAS, visual analogue scale; SD, standard deviation; PAL, palatal graft group; TUB, tuberosity graft group; W1, end of 1st post-operative week; W2, end of 2nd post-operative week.
*Significant difference between groups at specific time point (p<0.05).
†Multivariate analysis of variance; boldface indicates statistical significance (p<0.05).
PES outcomes
The mean PES score was 9.6±2.2 and 10.1±1.6 for PAL and TUB group, respectively, at T2. No significant intergroup differences were observed (p=0.54, Independent-samples Mann-Whitney U test).
Patient-reported outcomes (PROMs)
PROMs were almost identical between groups. All patients in both groups were “highly satisfied” with the esthetic outcome and reported that it was “highly likely” they would choose to undergo the same procedure again, except for one PAL group patient, who replied that it was “likely” they would choose to undergo the same procedure again.