Peri-implant Tissue Response With Use of Customized Healing AbutmentsNCT06125418
Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone
A study testing customized healing abutment and standard healing abutment in people with Peri-implant Tissue Response With Use of Customized Healing Abutments, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is: effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Tissue Response With Use of Customized Healing Abutments
- What is being tested?
- customized healing abutment and standard healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2022to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age;
- patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions
- sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;
- had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.
Who cannot join
- medical and general contraindications for the surgical procedure;
- heavy smokers (>10 cigarettes/day);
- an active infection at the implant site.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Prosthodontics, Faculty of Dentistry, Chiang Mai University
Chiang Mai, 50300
About this study
The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:
- effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.
Read the detailed description
Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.
- Being tested
- customized healing abutment, standard healing abutment
- Keywords
- dental implant, customized healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized healing abutmentProcedure or surgery
patients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.
standard healing abutmentProcedure or surgery
patients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.
| Study group | Role | What they receive |
|---|---|---|
| Customized group | Experimental | patients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle Receives: Procedure: customized healing abutment |
| Standard group | Experimental | patients who received standard titanium healing abutments following implant placement Receives: Procedure: standard healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue alteration
peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points
Measured: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
hard tissue alteration
peri-implant marginal bone change compared to baseline at different time points by periapical radiograph
Measured: T0 baseline before implant placement, 6month follow up, 12month follow up
volumetric alteration
peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan
Measured: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
Secondary outcomes (2)
pain numerical rating scale
pain assessment at time of final prosthesis delivery with scale from 0 to 10
Measured: at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery
pink esthetic score
pink esthetic score change compared to before implant treatment
Measured: T0 baseline before implant placement, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jun 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Tissue Response With Use of Customized Healing AbutmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients in each group will received different types of customized healing abutment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pimduen Rungsiyakull, Chiang Mai University
- Investigators
- Pimduen Rungsiyakull, AssocProfDr, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125418
- Sponsor's protocol ID
- 43/2022
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone
- ClinicalTrials.gov ID
- NCT06125418
- Acronym / sponsor ID
- 43/2022
- Keywords
- dental implant, customized healing abutment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:
- effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.
Detailed description
Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- patients in each group will received different types of customized healing abutment
| Arm | Type | Receives |
|---|---|---|
| Customized group | Experimental | Procedure: customized healing abutmentpatients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle |
| Standard group | Experimental | Procedure: standard healing abutmentpatients who received standard titanium healing abutments following implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age;
- patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions
- sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;
- had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.
Key exclusion criteria (3 listed)
- medical and general contraindications for the surgical procedure;
- heavy smokers (>10 cigarettes/day);
- an active infection at the implant site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| customized healing abutmentpatients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant. | Procedure or surgery | Customized group |
| standard healing abutmentpatients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant. | Procedure or surgery | Standard group |
Primary outcome
soft tissue alteration
Time frame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points
hard tissue alteration
Time frame: T0 baseline before implant placement, 6month follow up, 12month follow up
peri-implant marginal bone change compared to baseline at different time points by periapical radiograph
volumetric alteration
Time frame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan
2 secondary outcomes
pain numerical rating scale
Time frame: at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery
pink esthetic score
Time frame: T0 baseline before implant placement, 6 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pimduen Rungsiyakull, AssocProfDr principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing customized healing abutment and standard healing abutment in people with Peri-implant Tissue Response With Use of Customized Healing Abutments, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue alteration (time frame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.