Partially Edentulous MandibleNCT06818890
Response of Hard and Soft Tissue Around the Dental Implant to 2-Piece Abutment Vs Conventional Restorative Protocols
A study testing Definitive abutment base and Conventional Healing Abutment in people with Partially Edentulous Mandible and Dental Implant, run by Hasan Sarfaraz at 1 site in India.
Trial summary
The goal of the study is to determine whether using a two-piece definitive abutment, as opposed to a traditional two-stage healing abutment connection, will reduce the loss of crestal bone surrounding the implant and improve soft tissue adaption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partially Edentulous Mandible, Dental Implant, Soft Tissue Healing
- What is being tested?
- Definitive abutment base and Conventional Healing Abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 13 Mar 2019to 14 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate width and height of bone for the placement of appropriate size implant(s).
- Well-healed edentulous sites with a minimum of 2 mm of soft tissue thickness.
- Patients willing to participate by giving informed consent.
- Patients agreeing to attend the planned follow-up visits.
Who cannot join
- Medically compromised patients where surgery was contraindicated.
- Patients with poor oral hygiene and/or suffering from periodontal disease.
- Patients with insufficient quantity/quality of bone.
- Patient with edentulous sites with a lack of attached gingiva.
- Patients with edentulous sites with insufficient prosthetic space.
- Patients with a history of parafunctional occlusal habits.
- Tobacco or alcohol use or drug dependency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Stability of the Peri-implant Hard and Soft Tissues with the Use of One-time Definitive Abutment (on 1 Concept) and the Conventional 2 Stage Implant Connection
The goal of the study is to determine whether using a two-piece definitive abutment, as opposed to a traditional two-stage healing abutment connection, will reduce the loss of crestal bone surrounding the implant and improve soft tissue adaption. With the use of a manual periodontal probe, it will be recorded at four locations per implant. In order to prevent its removal during healing, an abutment base of the definitive restorative abutment will be positioned during implant surgery. Therefore, there is no departure from the standard course of treatment. An implant and crown will be used to replace a lost tooth, which will benefit the patients.
Benefit to society: more predictable and enhanced functional and aesthetic treatment outcomes.
Read more
Benefit to Scientific Advancement: This concept will be beneficial in maintaining the peri-implant soft tissue and bone levels.
Changes in interproximal bone levels will be measured in standardized periapical digital radiographs (x-rays) once a month, which is usually not associated with any complications.
The number of visits to the hospital: On the day of implant placement, 12th-week Impression Visit, 16th-week Prosthesis Placement, 20th-week 1st Month post prosthesis, follow up, 28th-week 3rd-month post prosthesis follow-up, 40th-week 6th-month post prosthesis follow-up, 64th-week 1-year follow-up after placing the definitive restoration. On every visit, radiographs will be taken. Patients should maintain regular oral hygiene to prevent future bone loss.
No one else shall be privy to participants' details. Implant treatment for the participant is free. The participant will give consent for any advisable and necessary dental procedures, medications, or anaesthetics to be administered by the attending dentist or his supervised staff for diagnostic purposes or for implant placement. Also give consent to make radiographic and photographic records; these records may also include study models, x-rays, and blood studies. If implants fail, then they will be retreated free of charge. Participants understood and acknowledged that they agreed to be part of this clinical study, will keep up with the follow-up appointments, and if they want, they can choose to drop out of the study anytime on the course of study. That there is no force or influence to participate, that he/she can take enough time to decide whether to participate, and that he/she can ask any doubts to the PI at any point in time.
Read the detailed description
An in-vivo clinical assessment and radiologic study protocol was developed and approved by the ethics committee of the Yenepoya University in Mangalore, in accordance with the Declaration of Helsinki. All patients provided written informed consent prior to the performance of any study procedures, and only data collected after the patients had signed informed consent were considered during the study analysis. A single-center, open, randomized parallel-group trial was conducted to compare the peri-implant tissue response of the abutment base treatment (test group) to that of a conventional restorative workflow with a healing abutment (control group). Patients underwent clinical assessments for the replacement of one or more missing mandibular posterior teeth with an implant-supported crown. Pre-operative CBCT scans were taken for all the patients to assess the quality and quantity of bone at the implant recipient sites.
All the surgeries were carried out by a skilled surgeon with minimal hard and soft tissue trauma during which NobelParallel TiUnite CC Implants (Nobel Biocare AB, Göteborg, Sweden) with diameters ranging from 4.3 mm to 5 mm and lengths from 10 mm to 11.5 mm were placed in healed edentulous sites in the posterior mandible in an equicrestal position. All procedures were performed using crestal incision with a full-thickness flap raised. The implants were placed at the crest of alveolar bone; no bone mill was used during the On1 base seating. The patients received broad-spectrum antibiotics for 5 days and analgesics for 2 days. The implant placement (IP) surgery was considered the baseline and was referred to as such. The On1 base (height 1.75 mm) and the On1 healing cap (Nobel Biocare AB) were placed in the test group, while the healing abutment (Conical Connection RP ø 6 x 5 mm; Nobel Biocare AB) was placed in the control group. The soft tissue was sutured (with sutures removed after 1 week), and the site was allowed a 12-week non-submerged healing, at which point the conventional tray impression was taken. At 16 weeks, a prosthetic crown (made in the university lab) was delivered, which was designated as the definitive prosthesis delivery (DPP), The follow-up appointments took place at 1-3-6 months and 1-year post-DPP.
- Being tested
- Definitive abutment base, Conventional Healing Abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive abutment baseDevice
Definite abutment base, this is a two-piece definitive abutment where the base is connected to the implant as soon as it is placed.This abutment will allow the tissues around the implant to heal undisturbed, thus, establishing a good and healthy periimplant soft and hard tissue with long-term stability.
Conventional Healing AbutmentDevice
A healing abutment of different diameters (4.3, 5, 6 mm) and heights (1.5, 3 mm) is placed on the day of the surgery, and the flaps are sutured around them to allow for tissue healing around the abutment to create an optimum emergence profile and tissue cuff around the implant and definitive abutment.
| Study group | Role | What they receive |
|---|---|---|
| Definite abutment base | Experimental | The On1 base (height 1.75 mm) and the On1 healing cap and On1 abutment (Nobel Biocare AB). it is a two-piece abutment of which the base is connected to the implant on the day of implant placement. Receives: Device: Definitive abutment base |
| Conventional healing abutment | Active comparator | Universal healing abutment and the universal base abutment Receives: Device: Conventional Healing Abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal Bone levels
The crestal bone level changes at the mesial and distal interproximal areas were captured at baseline (implant placement), 1-, 3-, 6 months, and 1-year post-restoration. Intra-oral periapical digital radiographs using the digital radiograph sensor (Gendex Dental Systems, Kavo, USA) and measured in millimeters using the measuring tool in the bundled software VixWin. The process was standardized by a positioning/paralleling device (Gendex, Kavo, Germany). The radiographs were verified for any distortion by measuring the distance between the head of the implant and the apex and using the known length of the implant. The mesial and distal crestal bone levels were calculated by determining the distance from the implant head to the first visible bone contact in millimeters.
Measured: I year follow up
Secondary outcomes (1)
Peri-Implant Tissue Health
A clinical peri-implant soft tissue health assessment was made using four different indices or measures; a positive finding in any of the two indices or measures would indicate compromised tissue health. It was recorded at 2 buccal and 2 lingual sites per implant with the aid of a manual periodontal probe at 4 time intervals: Day of Prosthesis Placement, 1-, 3-, 6-month, and 1-year post prosthesis placement. It was done using modified plaque index (mPLI with score 0-plaque seen to 3-visibly detectable plaque), modified sulcus bleeding index (mSBI with score 0-no bleeding to 3-heavy or profuse bleeding), mean probing depth (mPD) measured in millimeters with a plastic, color-coded periodontal probe (Mombelli et al. 1987) from 4 different sides: mesiobuccal, distobuccal, mesiolingual, and distolingual, and the width of peri-implant keratinized mucosa (KM) measured in millimeters in the mid-buccal and lingual sites.
Measured: I year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start13 Mar 2019
- Primary completion12 Dec 2020
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous MandibleStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Sarfaraz
- Sponsor type
- University, hospital or other
- Collaborators
- Yenepoya Dental College
- Responsible party
- Sponsor-investigator, Hasan Sarfaraz, Yenepoya Dental College
- Investigators
- Hasan Sarfaraz, MDS, Principal investigator, Yenepoya Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818890
- Sponsor's protocol ID
- 2018/193
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As a requirement for ethical clearance, we had informed the patient that their individual data will be kept confidential and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Stability of the Peri-implant Hard and Soft Tissues with the Use of One-time Definitive Abutment (on 1 Concept) and the Conventional 2 Stage Implant Connection
- ClinicalTrials.gov ID
- NCT06818890
- Acronym / sponsor ID
- 2018/193
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hasan SarfarazUniversity, hospital or other
- Collaborators
- Yenepoya Dental College
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 11 Feb 2025 (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 the study is to determine whether using a two-piece definitive abutment, as opposed to a traditional two-stage healing abutment connection, will reduce the loss of crestal bone surrounding the implant and improve soft tissue adaption. With the use of a manual periodontal probe, it will be recorded at four locations per implant. In order to prevent its removal during healing, an abutment base of the definitive restorative abutment will be positioned during implant surgery. Therefore, there is no departure from the standard course of treatment. An implant and crown will be used to replace a lost tooth, which will benefit the patients.
Benefit to society: more predictable and enhanced functional and aesthetic treatment outcomes.
Benefit to Scientific Advancement: This concept will be beneficial in maintaining the peri-implant soft tissue and bone levels.
Changes in interproximal bone levels will be measured in standardized periapical digital radiographs (x-rays) once a month, which is usually not associated with any complications.
The number of visits to the hospital: On the day of implant placement, 12th-week Impression Visit, 16th-week Prosthesis Placement, 20th-week 1st Month post prosthesis, follow up, 28th-week 3rd-month post prosthesis follow-up, 40th-week 6th-month post prosthesis follow-up, 64th-week 1-year follow-up after placing the definitive restoration. On every visit, radiographs will be taken. Patients should maintain regular oral hygiene to prevent future bone loss.
No one else shall be privy to participants' details. Implant treatment for the participant is free. The participant will give consent for any advisable and necessary dental procedures, medications, or anaesthetics to be administered by the attending dentist or his supervised staff for diagnostic purposes or for implant placement. Also give consent to make radiographic and photographic records; these records may also include study models, x-rays, and blood studies. If implants fail, then they will be retreated free of charge. Participants understood and acknowledged that they agreed to be part of this clinical study, will keep up with the follow-up appointments, and if they want, they can choose to drop out of the study anytime on the course of study. That there is no force or influence to participate, that he/she can take enough time to decide whether to participate, and that he/she can ask any doubts to the PI at any point in time.
Detailed description
An in-vivo clinical assessment and radiologic study protocol was developed and approved by the ethics committee of the Yenepoya University in Mangalore, in accordance with the Declaration of Helsinki. All patients provided written informed consent prior to the performance of any study procedures, and only data collected after the patients had signed informed consent were considered during the study analysis. A single-center, open, randomized parallel-group trial was conducted to compare the peri-implant tissue response of the abutment base treatment (test group) to that of a conventional restorative workflow with a healing abutment (control group). Patients underwent clinical assessments for the replacement of one or more missing mandibular posterior teeth with an implant-supported crown. Pre-operative CBCT scans were taken for all the patients to assess the quality and quantity of bone at the implant recipient sites.
All the surgeries were carried out by a skilled surgeon with minimal hard and soft tissue trauma during which NobelParallel TiUnite CC Implants (Nobel Biocare AB, Göteborg, Sweden) with diameters ranging from 4.3 mm to 5 mm and lengths from 10 mm to 11.5 mm were placed in healed edentulous sites in the posterior mandible in an equicrestal position. All procedures were performed using crestal incision with a full-thickness flap raised. The implants were placed at the crest of alveolar bone; no bone mill was used during the On1 base seating. The patients received broad-spectrum antibiotics for 5 days and analgesics for 2 days. The implant placement (IP) surgery was considered the baseline and was referred to as such. The On1 base (height 1.75 mm) and the On1 healing cap (Nobel Biocare AB) were placed in the test group, while the healing abutment (Conical Connection RP ø 6 x 5 mm; Nobel Biocare AB) was placed in the control group. The soft tissue was sutured (with sutures removed after 1 week), and the site was allowed a 12-week non-submerged healing, at which point the conventional tray impression was taken. At 16 weeks, a prosthetic crown (made in the university lab) was delivered, which was designated as the definitive prosthesis delivery (DPP), The follow-up appointments took place at 1-3-6 months and 1-year post-DPP.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definite abutment base | Experimental | Device: Definitive abutment baseThe On1 base (height 1.75 mm) and the On1 healing cap and On1 abutment (Nobel Biocare AB). it is a two-piece abutment of which the base is connected to the implant on the day of implant placement. |
| Conventional healing abutment | Active comparator | Device: Conventional Healing AbutmentUniversal healing abutment and the universal base abutment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adequate width and height of bone for the placement of appropriate size implant(s).
- Well-healed edentulous sites with a minimum of 2 mm of soft tissue thickness.
- Patients willing to participate by giving informed consent.
- Patients agreeing to attend the planned follow-up visits.
Key exclusion criteria (7 listed)
- Medically compromised patients where surgery was contraindicated.
- Patients with poor oral hygiene and/or suffering from periodontal disease.
- Patients with insufficient quantity/quality of bone.
- Patient with edentulous sites with a lack of attached gingiva.
- Patients with edentulous sites with insufficient prosthetic space.
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 |
|---|---|---|
| Definitive abutment baseDefinite abutment base, this is a two-piece definitive abutment where the base is connected to the implant as soon as it is placed.This abutment will allow the tissues around the implant to heal undisturbed, thus, establishing a good and healthy periimplant soft and hard tissue with long-term stability. | Device | Definite abutment base |
| Conventional Healing AbutmentA healing abutment of different diameters (4.3, 5, 6 mm) and heights (1.5, 3 mm) is placed on the day of the surgery, and the flaps are sutured around them to allow for tissue healing around the abutment to create an optimum emergence profile and tissue cuff around the implant and definitive abutment. | Device | Conventional healing abutment |
Primary outcome
Crestal Bone levels
Time frame: I year follow up
The crestal bone level changes at the mesial and distal interproximal areas were captured at baseline (implant placement), 1-, 3-, 6 months, and 1-year post-restoration. Intra-oral periapical digital radiographs using the digital radiograph sensor (Gendex Dental Systems, Kavo, USA) and measured in millimeters using the measuring tool in the bundled software VixWin. The process was standardized by a positioning/paralleling device (Gendex, Kavo, Germany). The radiographs were verified for any distortion by measuring the distance between the head of the implant and the apex and using the known length of the implant. The mesial and distal crestal bone levels were calculated by determining the distance from the implant head to the first visible bone contact in millimeters.
1 secondary outcome
Peri-Implant Tissue Health
Time frame: I year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No. As a requirement for ethical clearance, we had informed the patient that their individual data will be kept confidential and will not be shared.
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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.
Hasan Sarfaraz, MDS principal investigator
Yenepoya Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Definitive abutment base and Conventional Healing Abutment in people with Partially Edentulous Mandible and Dental Implant, run by Hasan Sarfaraz at 1 site in India.
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 7 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: finished, as of the sponsor's last update on 11 Feb 2025. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Crestal Bone levels (time frame: I year follow up). 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 11 Feb 2025.