Customized Healing AbutmentNCT07196293
A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile Around Implant
A study testing Customized Healing Abutment - bulk fill composite and customized healing abutments - Bis acryl composite materials in people with Customized Healing Abutment and Dental Implant, run by Amrita Institute of Medical Sciences & Research Center at 1 site in India.
Trial summary
The study focuses on the critical role of the gingival emergence profile in the success of dental implants, emphasizing its importance for both peri-implant health and esthetics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Customized Healing Abutment, Dental Implant, Composite Resin
- What is being tested?
- Customized Healing Abutment - bulk fill composite and customized healing abutments - Bis acryl composite materials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2023to 30 Aug 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Edentulous spaces to be replaced with implant-supported single crowns.
- Antagonistic natural tooth present and sound (sound periodontium) (Stable occlusion and opposing dentition)
- Good general periodontal health
- Good general health.
- Willing to participate in the study and able to sign informed consent. (Ability to attend all follow-up appointments.)
Who cannot join
- Untreated caries or periapical lesions in the opposing natural antagonistic tooth.
- Active periodontal disease.
- major active systemic disease affecting soft tissue healing
- Multiple implant supported restorations already present.
- Long edentulous spaces.
- Complete edentulous cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile and Evaluation of Peri-implant Soft Tissue; an In-vivo Study
The study focuses on the critical role of the gingival emergence profile in the success of dental implants, emphasizing its importance for both peri-implant health and esthetics. The research aims to evaluate and compare the effectiveness of two common, cost-effective dental materials-light-cure composite and Protemp (a bis-acryl composite resin)-for fabricating customized healing abutments. By assessing the peri-implant tissue response to these materials, the study seeks to determine which is more suitable for creating an optimal, natural-looking soft tissue contour, thereby providing dentists with a practical and reliable alternative to more expensive options like PEEK.
- Being tested
- Customized Healing Abutment - bulk fill composite, customized healing abutments - Bis acryl composite materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized Healing Abutment - bulk fill compositeProcedure or surgery
instead of standard healing abutments , customization was done using bulk fill composite
customized healing abutments - Bis acryl composite materialsProcedure or surgery
customized healing abutments with bis acryl composite material was used instead of standard healing abutments
| Study group | Role | What they receive |
|---|---|---|
| standard titanium healing abutment | No intervention | standard titanium healing abutments used |
| customized healing abutment - bulk-fill flowable composite | Active comparator | Not described Receives: Procedure: Customized Healing Abutment - bulk fill composite |
| customized healing abutment - Protemp 4 (Bis-Acryl composite) | Active comparator | Not described Receives: Procedure: customized healing abutments - Bis acryl composite materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index (GI)
Gingival Index (GI): This index is used to evaluate inflammation of the gums around the implant.
Scale: 0 to 3.
Interpretation: A higher score indicates a worse outcome, signifying greater gingival inflammation.
Measured: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Probing depth (PI)
Probing Depth (PD): This is a direct clinical measurement, not a scored scale, taken in millimeters at six points around the implant.
Interpretation: Deeper measurements are generally associated with less healthy peri-implant tissue. Therefore, a lower value indicates a better clinical outcome.
Measured: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Pink Esthetic Score (PES)
Pink Esthetic Score (PES): This score is used to assess the aesthetic quality of the soft tissue surrounding the implant restoration.
Scale: 0 to 14.
Interpretation: A higher score indicates a better and more aesthetically pleasing outcome.
Measured: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Pain Numeric Scale
Pain Numeric Rating Scale (NRS): This scale measures the patient's subjective experience of pain during the insertion of the final prosthesis.
Scale: 0 ("no pain") to 10 ("worst pain imaginable").
Interpretation: A higher score indicates a worse outcome, representing more severe pain.
Measured: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Secondary outcomes (1)
Plaque Index (PI)
Plaque Index (PI): This index is used to quantify the amount of dental plaque present on the implant restoration.
Scale: 0 to 3.
Interpretation: A higher score indicates a worse outcome, corresponding to a greater accumulation of plaque.
Measured: T2: At the one-month follow-up appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Sep 2023
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Customized Healing AbutmentStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amrita Institute of Medical Sciences & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhavin Milind Patil, Amrita Institute of Medical Sciences & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196293
- Sponsor's protocol ID
- ECASM-AIMS-2023-356
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile and Evaluation of Peri-implant Soft Tissue; an In-vivo Study
- ClinicalTrials.gov ID
- NCT07196293
- Acronym / sponsor ID
- ECASM-AIMS-2023-356
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amrita Institute of Medical Sciences & Research CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 29 Sep 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 study focuses on the critical role of the gingival emergence profile in the success of dental implants, emphasizing its importance for both peri-implant health and esthetics. The research aims to evaluate and compare the effectiveness of two common, cost-effective dental materials-light-cure composite and Protemp (a bis-acryl composite resin)-for fabricating customized healing abutments. By assessing the peri-implant tissue response to these materials, the study seeks to determine which is more suitable for creating an optimal, natural-looking soft tissue contour, thereby providing dentists with a practical and reliable alternative to more expensive options like PEEK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard titanium healing abutment | No intervention | –standard titanium healing abutments used |
| customized healing abutment - bulk-fill flowable composite | Active comparator | Procedure: Customized Healing Abutment - bulk fill composite |
| customized healing abutment - Protemp 4 (Bis-Acryl composite) | Active comparator | Procedure: customized healing abutments - Bis acryl composite materials |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years.
- Edentulous spaces to be replaced with implant-supported single crowns.
- Antagonistic natural tooth present and sound (sound periodontium) (Stable occlusion and opposing dentition)
- Good general periodontal health
- Good general health.
Key exclusion criteria (6 listed)
- Untreated caries or periapical lesions in the opposing natural antagonistic tooth.
- Active periodontal disease.
- major active systemic disease affecting soft tissue healing
- Multiple implant supported restorations already present.
- Long edentulous spaces.
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 Abutment - bulk fill compositeinstead of standard healing abutments , customization was done using bulk fill composite | Procedure or surgery | customized healing abutment - bulk-fill flowable composite |
| customized healing abutments - Bis acryl composite materialscustomized healing abutments with bis acryl composite material was used instead of standard healing abutments | Procedure or surgery | customized healing abutment - Protemp 4 (Bis-Acryl composite) |
Primary outcome
Gingival Index (GI)
Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Gingival Index (GI): This index is used to evaluate inflammation of the gums around the implant. Scale: 0 to 3. Interpretation: A higher score indicates a worse outcome, signifying greater gingival inflammation.
Probing depth (PI)
Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Probing Depth (PD): This is a direct clinical measurement, not a scored scale, taken in millimeters at six points around the implant. Interpretation: Deeper measurements are generally associated with less healthy peri-implant tissue. Therefore, a lower value indicates a better clinical outcome.
Pink Esthetic Score (PES)
Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Pink Esthetic Score (PES): This score is used to assess the aesthetic quality of the soft tissue surrounding the implant restoration. Scale: 0 to 14. Interpretation: A higher score indicates a better and more aesthetically pleasing outcome.
Pain Numeric Scale
Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Pain Numeric Rating Scale (NRS): This scale measures the patient's subjective experience of pain during the insertion of the final prosthesis. Scale: 0 ("no pain") to 10 ("worst pain imaginable"). Interpretation: A higher score indicates a worse outcome, representing more severe pain.
1 secondary outcome
Plaque Index (PI)
Time frame: T2: At the one-month follow-up appointment.
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 29 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 - bulk fill composite and customized healing abutments - Bis acryl composite materials in people with Customized Healing Abutment and Dental Implant, run by Amrita Institute of Medical Sciences & Research Center 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 6 inclusion and 6 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 29 Sep 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?
Gingival Index (GI) (time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.). The study lists 4 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 29 Sep 2025.