UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059621 |
|---|---|
| Receipt number | R000068196 |
| Scientific Title | Soft tissue volume change around dental implants with subepithelial connective tissue grafting |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/11/02 13:32:08 |
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Basic information
Public title
Soft tissue volume change around dental implants with subepithelial connective tissue grafting
Acronym
Soft tissue volume change around dental implants with subepithelial connective tissue grafting
Scientific Title
Soft tissue volume change around dental implants with subepithelial connective tissue grafting
Scientific Title:Acronym
Soft tissue volume change around dental implants with subepithelial connective tissue grafting
Region
| Japan |
Condition
Condition
insufficient peri-implant soft tissue
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate whether there are any differences in the volume change around implants when using connective tissue grafts harvested from the lateral palate or tuberosity and to assess possible differences in postoperative pain levels.
Basic objectives2
Others
Basic objectives -Others
postoperative pain
marginal bone change
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the soft tissue volume change around implant
Key secondary outcomes
postoperative pain
marginal bone level around implant
pocket depth
bleeding on probing
pink esthetic score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
harvest from maxillary tuberosity
Interventions/Control_2
harvest from palate
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with at least 20 teeth remaining.
Patients with good oral hygiene status (plaque score of <25%).
Patients with a single missing tooth at the anterior or premolar area.
Adequate bone volume confirmed by preoperative radiographs and computed tomography scans.
Presence of at least 2 mm of keratinized gingiva.
The opposing teeth must be either natural teeth or fixed prosthetics supported by natural teeth or implants.
Key exclusion criteria
Pregnancy.
Systemic diseases (poorly controlled diabetes and hypertension).
Smokers (those who smoke>10 cigarettes per day).
Presence of untreated caries or periodontal disease (with residual periodontal pockets greater than or equal to 4 mm).
History of radiation therapy in the head and neck regions.
Presence of bruxism.
Abnormal implant placement position.
Lack of initial implant stability.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsurou |
| Middle name | |
| Last name | Odatsu |
Organization
Nagasaki University
Division name
Department of Applied Prosthodontics
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7686
odatsu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsurou |
| Middle name | |
| Last name | Odatsu |
Organization
Nagasaki University
Division name
Department of Applied Prosthodontics
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7686
Homepage URL
odatsu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Tetsurou Odatsu
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethic committee of the Graduate School of Biomedical Sciences, Nagasaki University
Address
1-12-4, Sakamoto, Nagasaki
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.shika-implant.org/shika/archives/dai54/index.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.shika-implant.org/shika/archives/dai54/index.html
Number of participants that the trial has enrolled
30
Results
The connective tissue graft around dental implants from the palate or tuberosity had similar clinical outcomes in terms of volume change 6 months after setting the provisional restoration if the graft was harvested from the lamina propria. However, postoperative pain levels were lower with grafts harvested from the tuberosity than with those harvested from the palate.
Results date posted
| 2025 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 30 participants were enrolled in this study
Participant flow
Participants were first screened for eligibility and provided written informed consent. Connective tissue grafting harvested from palate or tuberosity was performed during the second surgical procedure for implants that had undergone submerged healing. To assess postoperative pain, a visual analog scale, , that is, a horizontal linear scale with"none" on the left side and "worst pain possible# on the right side, was used during the postoperative healing period until the sutures were removed. Forms were marked on the day of suture removal. To evaluate the volumetric changes in soft tissues, impressions of the implant sites, standardized intraoral photographs and radiographs were taken at the time point of provisional restoration provided(baseline), 3months, 6months after baseline, and every 6 months thereafter.
Adverse events
none
Outcome measures
soft tissue volume change around implant
marginal bone level around implant
postoperative pain
pocket depth
bleeding on probing
pink esthetic score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068196
