Trial Outcomes & Findings for Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions (NCT NCT05441683)
NCT ID: NCT05441683
Last Updated: 2025-05-11
Results Overview
Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
1 day
Results posted on
2025-05-11
Participant Flow
Unit of analysis: teeth
Participant milestones
| Measure |
HEI Group
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Overall Study
STARTED
|
11 66
|
11 63
|
|
Overall Study
COMPLETED
|
10 60
|
10 57
|
|
Overall Study
NOT COMPLETED
|
1 6
|
1 6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HEI Group
n=60 teeth
Periodontal Accelerated Osteogenic Orthodontics (PAOO) with horizontally extending incisions on both sides
horizontally extending incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
Periodontal Accelerated Osteogenic Orthodontics (PAOO) with vertical releasing incisions on both sides
vertical releasing incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted.
|
Total
n=117 teeth
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.20 years
STANDARD_DEVIATION 4.64 • n=10 Participants
|
27.20 years
STANDARD_DEVIATION 5.07 • n=10 Participants
|
27.20 years
STANDARD_DEVIATION 4.73 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 dayTiming will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Surgery Time
|
57.66 minutes
Standard Deviation 5.01
|
68.50 minutes
Standard Deviation 13.50
|
SECONDARY outcome
Timeframe: 12 monthsDistance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Probing Depth (PD)
baseline
|
1.86 millimeter
Standard Deviation 0.32
|
1.86 millimeter
Standard Deviation 1.83
|
|
Probing Depth (PD)
3 months change
|
-0.05 millimeter
Standard Deviation 0.45
|
0.06 millimeter
Standard Deviation 0.42
|
|
Probing Depth (PD)
6 months change
|
0.03 millimeter
Standard Deviation 0.43
|
0.13 millimeter
Standard Deviation 0.56
|
|
Probing Depth (PD)
12 months change
|
-0.07 millimeter
Standard Deviation 0.58
|
-0.05 millimeter
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: 12 monthsDistance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Clinical Attachment Level (CAL)
baseline
|
0.66 millimeter
Standard Deviation 1.05
|
0.52 millimeter
Standard Deviation 0.89
|
|
Clinical Attachment Level (CAL)
3 months change
|
0.05 millimeter
Standard Deviation 0.77
|
0.05 millimeter
Standard Deviation 0.75
|
|
Clinical Attachment Level (CAL)
6 months change
|
0.01 millimeter
Standard Deviation 0.80
|
0.16 millimeter
Standard Deviation 0.76
|
|
Clinical Attachment Level (CAL)
12 months change
|
0.15 millimeter
Standard Deviation 0.85
|
-0.15 millimeter
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 12 monthsFrom mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Keratinized Gingival Width (KGW)
baseline
|
2.97 millimeter
Standard Deviation 0.72
|
3.50 millimeter
Standard Deviation 1.30
|
|
Keratinized Gingival Width (KGW)
3 months change
|
0.50 millimeter
Standard Deviation 0.86
|
0.07 millimeter
Standard Deviation 1.39
|
|
Keratinized Gingival Width (KGW)
6 months change
|
0.37 millimeter
Standard Deviation 1.12
|
0.41 millimeter
Standard Deviation 1.38
|
|
Keratinized Gingival Width (KGW)
12 months change
|
0.85 millimeter
Standard Deviation 1.13
|
0.71 millimeter
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 12 monthsDistance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Gingival Recession Depth (GRD)
baseline
|
-0.75 millimeter
Standard Deviation 1.03
|
-0.96 millimeter
Standard Deviation 1.25
|
|
Gingival Recession Depth (GRD)
3 months change
|
-0.06 millimeter
Standard Deviation 0.77
|
0.14 millimeter
Standard Deviation 0.67
|
|
Gingival Recession Depth (GRD)
6 months change
|
-0.08 millimeter
Standard Deviation 0.99
|
0.21 millimeter
Standard Deviation 0.70
|
|
Gingival Recession Depth (GRD)
12 months change
|
-0.04 millimeter
Standard Deviation 0.89
|
0.01 millimeter
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 12 monthsthe distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Root Length
baseline
|
11.11 millimeter
Standard Deviation 1.81
|
12.03 millimeter
Standard Deviation 2.45
|
|
Root Length
6 months change
|
-0.30 millimeter
Standard Deviation 0.78
|
-0.45 millimeter
Standard Deviation 1.09
|
|
Root Length
12 months change
|
-0.44 millimeter
Standard Deviation 1.00
|
-064 millimeter
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 12 monthsthe distance from the cemento-enamel junction to the crest of the labial alveolar bone. It will be measured at baseline, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Vertical Bone Height (VBL)
baseline
|
4.28 millimeter
Standard Deviation 2.99
|
5.06 millimeter
Standard Deviation 3.00
|
|
Vertical Bone Height (VBL)
6 months change
|
-2.95 millimeter
Standard Deviation 2.75
|
-3.17 millimeter
Standard Deviation 2.76
|
|
Vertical Bone Height (VBL)
12 months change
|
-2.69 millimeter
Standard Deviation 2.96
|
-2.94 millimeter
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: 12 monthsAlveolar bone width measured at 2 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
baseline
|
0.33 millimeter
Standard Deviation 0.47
|
0.18 millimeter
Standard Deviation 0.40
|
|
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
6 months change
|
0.80 millimeter
Standard Deviation 0.86
|
0.45 millimeter
Standard Deviation 0.69
|
|
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
12 months change
|
0.67 millimeter
Standard Deviation 0.78
|
0.39 millimeter
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 12 monthsAlveolar bone width measured at 4 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
baseline
|
0.43 millimeter
Standard Deviation 0.48
|
0.39 millimeter
Standard Deviation 0.50
|
|
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
6 months change
|
1.71 millimeter
Standard Deviation 1.00
|
0.96 millimeter
Standard Deviation 0.68
|
|
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
12 months change
|
1.44 millimeter
Standard Deviation 0.73
|
0.94 millimeter
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 12 monthsAlveolar bone width measured at 6 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Outcome measures
| Measure |
HEI Group
n=60 teeth
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=57 teeth
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
baseline
|
0.45 millimeter
Standard Deviation 0.50
|
0.51 millimeter
Standard Deviation 0.46
|
|
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
6 months change
|
2.47 millimeter
Standard Deviation 1.11
|
1.38 millimeter
Standard Deviation 0.85
|
|
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
12 months change
|
1.92 millimeter
Standard Deviation 0.87
|
1.13 millimeter
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 12 monthsGingival scarring was evaluated at 12 months postoperatively through visual inspection. Participants were classified as scar-positive if any visible scar was present at the surgical site, including normotrophic scars (flat and white) and pathological scars (raised or irregular in shape). Each participant was counted once regardless of scar characteristics.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Number of Participants With Visible Scarring
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 weeksmeasured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Pain Level
1 week
|
2.90 score on a scale
Standard Deviation 1.20
|
2.70 score on a scale
Standard Deviation 1.16
|
|
Pain Level
2 weeks
|
1.60 score on a scale
Standard Deviation 1.08
|
1.50 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 2 weeksmembrane exposure was observed and assessed as a binary outcome (yes/no). Recorded "no" if there is no membrane exposure, and "yes" if there is any membrane exposure.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Membrane Exposure
yes
|
3 Participants
|
1 Participants
|
|
Membrane Exposure
no
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 weeksrecorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling. It will be measured at 1 and 2 weeks after surgery.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Facial Swelling
1 week · 0
|
6 Participants
|
4 Participants
|
|
Facial Swelling
1 week · 1
|
4 Participants
|
6 Participants
|
|
Facial Swelling
1 week · 2
|
0 Participants
|
0 Participants
|
|
Facial Swelling
2 weeks · 0
|
10 Participants
|
10 Participants
|
|
Facial Swelling
2 weeks · 1
|
0 Participants
|
0 Participants
|
|
Facial Swelling
2 weeks · 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksrecorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness. It will be measured at 1 and 2 weeks after surgery.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Mucosal Color
1 week · 0
|
0 Participants
|
0 Participants
|
|
Mucosal Color
1 week · 1
|
10 Participants
|
9 Participants
|
|
Mucosal Color
1 week · 2
|
0 Participants
|
1 Participants
|
|
Mucosal Color
2 weeks · 0
|
0 Participants
|
1 Participants
|
|
Mucosal Color
2 weeks · 1
|
10 Participants
|
9 Participants
|
|
Mucosal Color
2 weeks · 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksrecorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.It will be measured at 1 and 2 weeks after surgery.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Mucosa Edema
1 week · 0
|
1 Participants
|
0 Participants
|
|
Mucosa Edema
1 week · 1
|
7 Participants
|
6 Participants
|
|
Mucosa Edema
1 week · 2
|
2 Participants
|
4 Participants
|
|
Mucosa Edema
2 weeks · 0
|
3 Participants
|
3 Participants
|
|
Mucosa Edema
2 weeks · 1
|
7 Participants
|
7 Participants
|
|
Mucosa Edema
2 weeks · 2
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayThe net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2.
Outcome measures
| Measure |
HEI Group
n=10 Participants
PAOO with horizontally extending incisions on both sides
horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
|
VRI Group
n=10 Participants
PAOO with vertical releasing incisions on both sides
Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
|
|---|---|---|
|
Particulate Bone Grafting Material Weight
|
0.83 g
Standard Deviation 0.23
|
0.79 g
Standard Deviation 0.25
|
Adverse Events
HEI Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VRI Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yan-Min Wu
Department of Periodontology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Phone: +86-13757119560
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place