Immediate Dental ImplantNCT04449302
Evaluation of Papilla Index Around Immediate Mandibular Molar Implants Using Customized Healing Abutment Versus Submerged Healing
A study testing Immediate molar implant with customized healing abutment in people with Immediate Dental Implant, run by Cairo University at 1 site in Egypt.
Trial summary
The original implant treatment protocol recommended that the implant should be placed in a fully healed site and covered with mucosa after placement to ensure osseointegration. The reason was to protect the implant site from bacterial contamination and to avoid loading of the implant. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant
- What is being tested?
- Immediate molar implant with customized healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2021to 9 Oct 2023
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age between 20 and 70 years old.
- Patients with non-restorable mandibular molars
- Medically free.
- Integrity of the extraction socket wall
- Patients who are able to sign an informed consent form.
- Cooperative, motivated and hygiene conscious Patients.
- Patients who are able to come for the follow up appointments.
Who cannot join
- Patients with compromised general health conditions that would impair bone healing including: Past or present history of bone irradiation Patients taking bisphosphonates
- Teeth with acute periapical pathosis
- Heavy Smokers
- Parafunctional habits
- Pregnant females
- Drug abusers
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Papilla Index Around Immediate Implant Placement in Mandibular Molars Using Chairside Customized Healing Abutment Versus Submerged Healing :A Randomized Controlled Clinical Trial
The original implant treatment protocol recommended that the implant should be placed in a fully healed site and covered with mucosa after placement to ensure osseointegration. The reason was to protect the implant site from bacterial contamination and to avoid loading of the implant. After that, a second stage surgical procedure had to be performed to expose the implant to connect the abutment. However, it was shown that a one stage or non-submerged (NS) approach can lead to successful and predictable outcomes.
Customized healing abutments can be used in the non-submerged protocol, protecting and containing the bone substitute during healing, preserving the alveolar contour, preventing food impaction, and eliminating the need for a second stage surgery and. By means of this technique, critical and subcritical contours can be projected speeding up the peri-implant soft tissue conditioning phase in order to achieve final natural-like restorations.
This randomized controlled trial will compare the clinical and radiographic hard and soft tissue changes using chairside customized healing abutment versus submerged healing following immediate implant placement in mandibular molars through measuring the horizontal ridge changes by CBCT , the crestal bone loss by a standardized digital x-ray and the soft tissue changes by the pink esthetic score (PES).
Read the detailed description
Immediate implant placement in extraction sockets was used to (i) reduce the number of surgical procedures (ii) preserve the dimensions of the alveolar ridge and (iii) reduce the interval between the removal of the tooth and the insertion of the implant supported restoration.
Flapless extraction is a technique aimed towards leaving the periosteum undisturbed by extracting the tooth with minimal trauma using periotomes without flap reflection. They also found less crestal bone loss around immediate implants placed in flapless extraction sockets in compared to implants placed by elevating a flap, due to greater blood supply and less postoperative swelling and pain.
Submerged healing and absence of loading was proposed during the early stage of osseointegration. Such a two-stage approach, based on a period of submerged healing aimed at optimizing the process of new bone formation and remodeling that follows implant placement is considered the gold standard procedure. It requires a second surgery to connect the abutment. This second surgical procedure is generally a minor one; thus, it is not particularly uncomfortable for the patient and offers the possibility to perform soft tissue management procedures around healed implants which may result in a better long-term prognosis. On the other hand, the desire to provide faster and less invasive treatment to patients, as well as to avoid postponing implant load and prosthesis delivery, has led to one-stage surgery (non-submerged healing). In this approach the implant and the healing abutment are placed in a single procedure so it remains exposed in the oral cavity during the osseointegration period.
The provisional restoration or a custom abutment can act as a "prosthetic socket-sealing" to protect, contain and maintain the blood clot and bone-graft material during the healing phase of treatment.
The aim of this randomized clinical trial is to evaluate the clinical and radiographic hard and soft tissue changes using chairside customized healing abutment versus submerged healing following immediate implant placement in mandibular molars.
- Conditions
- Immediate Dental Implant
- Being tested
- Immediate molar implant with customized healing abutment
- Keywords
- immediate dental implants, customized healing abutment, submerged healing, papilla index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate molar implant with customized healing abutmentProcedure or surgery
Patients will receive an immediate implant with customized healing abutment
- Atraumatic extraction without flap elevation using periotomes and elevators then sectioning of the roots will be performed to preserve the interseptal bone.
- The drilling will be performed starting from the pilot drill in the interseptal bone to the twisting drills according to the manufacturer's instructions to the selected implant size. The implant is to be placed immediately then the insertion torque will be measured using a torque wrench. In order to place the customized healing abutment, the insertion torque should be more than 25 ncm.
- The gap distance will be filled by xenograft, a plastic abutment will be screwed in place then a flowable composie resin will be applied around into small amounts and cured to take the soft tissue contour then finishing and polishing of the customized healing abutment will be done.
| Study group | Role | What they receive |
|---|---|---|
| Immediate molar implant with customized healing abutment | Experimental | Patients will receive an immediate mandibular molar implant with customized healing abutment Receives: Procedure: Immediate molar implant with customized healing abutment |
| Immediate molar implant with submerged healing | Active comparator | Patients will receive an immediate mandibular molar implant with submerged healing Receives: Procedure: Immediate molar implant with customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilla Index
JEMT Index (mm.)
Measured: 1 year follow up
Secondary outcomes (4)
Hard tissue horizontal ridge changes (bucco lingual)
CBCT (mm.)
Measured: 1 year follow up
Crestal bone loss
Standardized periapical Xray (mm.)
Measured: 1 year follow up
Soft tissue profile
PES (Pink esthetic score ) Score from 0 to 14
Measured: 1 year follow up
Satisfaction index
Satisfaction patient questionnaire Score from 0 to 100
Measured: 1 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 posted26 Jun 2020
- Study start25 Mar 2021
- Primary completion26 Aug 2022
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immediate Dental ImplantStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- it is randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nabil Ibrahem, Cairo University
- Investigators
- Omnia Aboul Dahab, Phd, Study chair, Cairo UniversityHani El-Nahas, Phd, Study chair, Cairo UniversityOmnia K. Tawfik, Phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449302
- Sponsor's protocol ID
- PER 6-3-2
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will check with my study chairs
Publications
Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.
PubMed 31797548
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Papilla Index Around Immediate Implant Placement in Mandibular Molars Using Chairside Customized Healing Abutment Versus Submerged Healing :A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04449302
- Acronym / sponsor ID
- PER 6-3-2
- Conditions
- Immediate Dental Implant
- Keywords
- immediate dental implants, customized healing abutment, submerged healing, papilla index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 26 Jun 2020 (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 original implant treatment protocol recommended that the implant should be placed in a fully healed site and covered with mucosa after placement to ensure osseointegration. The reason was to protect the implant site from bacterial contamination and to avoid loading of the implant. After that, a second stage surgical procedure had to be performed to expose the implant to connect the abutment. However, it was shown that a one stage or non-submerged (NS) approach can lead to successful and predictable outcomes.
Customized healing abutments can be used in the non-submerged protocol, protecting and containing the bone substitute during healing, preserving the alveolar contour, preventing food impaction, and eliminating the need for a second stage surgery and. By means of this technique, critical and subcritical contours can be projected speeding up the peri-implant soft tissue conditioning phase in order to achieve final natural-like restorations.
This randomized controlled trial will compare the clinical and radiographic hard and soft tissue changes using chairside customized healing abutment versus submerged healing following immediate implant placement in mandibular molars through measuring the horizontal ridge changes by CBCT , the crestal bone loss by a standardized digital x-ray and the soft tissue changes by the pink esthetic score (PES).
Detailed description
Immediate implant placement in extraction sockets was used to (i) reduce the number of surgical procedures (ii) preserve the dimensions of the alveolar ridge and (iii) reduce the interval between the removal of the tooth and the insertion of the implant supported restoration.
Flapless extraction is a technique aimed towards leaving the periosteum undisturbed by extracting the tooth with minimal trauma using periotomes without flap reflection. They also found less crestal bone loss around immediate implants placed in flapless extraction sockets in compared to implants placed by elevating a flap, due to greater blood supply and less postoperative swelling and pain.
Submerged healing and absence of loading was proposed during the early stage of osseointegration. Such a two-stage approach, based on a period of submerged healing aimed at optimizing the process of new bone formation and remodeling that follows implant placement is considered the gold standard procedure. It requires a second surgery to connect the abutment. This second surgical procedure is generally a minor one; thus, it is not particularly uncomfortable for the patient and offers the possibility to perform soft tissue management procedures around healed implants which may result in a better long-term prognosis. On the other hand, the desire to provide faster and less invasive treatment to patients, as well as to avoid postponing implant load and prosthesis delivery, has led to one-stage surgery (non-submerged healing). In this approach the implant and the healing abutment are placed in a single procedure so it remains exposed in the oral cavity during the osseointegration period.
The provisional restoration or a custom abutment can act as a "prosthetic socket-sealing" to protect, contain and maintain the blood clot and bone-graft material during the healing phase of treatment.
The aim of this randomized clinical trial is to evaluate the clinical and radiographic hard and soft tissue changes using chairside customized healing abutment versus submerged healing following immediate implant placement in mandibular molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- it is randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Immediate molar implant with customized healing abutment | Experimental | Procedure: Immediate molar implant with customized healing abutmentPatients will receive an immediate mandibular molar implant with customized healing abutment |
| Immediate molar implant with submerged healing | Active comparator | Procedure: Immediate molar implant with customized healing abutmentPatients will receive an immediate mandibular molar implant with submerged healing |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients age between 20 and 70 years old.
- Patients with non-restorable mandibular molars
- Medically free.
- Integrity of the extraction socket wall
- Patients who are able to sign an informed consent form.
Key exclusion criteria (7 listed)
- Patients with compromised general health conditions that would impair bone healing including: Past or present history of bone irradiation Patients taking bisphosphonates
- Teeth with acute periapical pathosis
- Heavy Smokers
- Parafunctional habits
- Pregnant females
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 |
|---|---|---|
| Immediate molar implant with customized healing abutmentPatients will receive an immediate implant with customized healing abutment 1. Atraumatic extraction without flap elevation using periotomes and elevators then sectioning of the roots will be performed to preserve the interseptal bone. 2. The drilling will be performed starting from the pilot drill in the interseptal bone to the twisting drills according to the manufacturer's instructions to the selected implant size. The implant is to be placed immediately then the insertion torque will be measured using a torque wrench. In order to place the customized healing abutment, the insertion torque should be more than 25 ncm. 3. The gap distance will be filled by xenograft, a plastic abutment will be screwed in place then a flowable composie resin will be applied around into small amounts and cured to take the soft tissue contour then finishing and polishing of the customized healing abutment will be done. | Procedure or surgery | Immediate molar implant with customized healing abutment, Immediate molar implant with submerged healing |
Primary outcome
Papilla Index
Time frame: 1 year follow up
JEMT Index (mm.)
4 secondary outcomes
Hard tissue horizontal ridge changes (bucco lingual)
Time frame: 1 year follow up
Crestal bone loss
Time frame: 1 year follow up
Soft tissue profile
Time frame: 1 year follow up
Satisfaction index
Time frame: 1 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 24 Jun 2026.
- Background: PubMed 31797548Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.
- Individual participant dataSharing planned: Undecided. i will check with my study chairs
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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.
Omnia Aboul Dahab, Phd study chair
Cairo University
Hani El-Nahas, Phd study chair
Cairo University
Omnia K. Tawfik, Phd study chair
Cairo 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 Immediate molar implant with customized healing abutment in people with Immediate Dental Implant, run by Cairo University at 1 site in Egypt.
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 7 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 24 Jun 2026. 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 Egypt. 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?
Papilla Index (time frame: 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449302, which also lists 1 linked publication.
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 24 Jun 2026.