Immediate Temporization and Soft Tissue Augmentation Around Delayed ImplantsPhase 3NCT03770975
Comparison of Peri Implant Soft Tissue Esthetics With Immediate Temporization With and Without Subepithelial Connective Tissue Graft
A Phase 3 study testing delayed implant with immediate provisionaliztion and soft tissue graft and delayed implant placement with immediate provisionalization in people with Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants
- What is being tested?
- delayed implant with immediate provisionaliztion and soft tissue graft and delayed implant placement with immediate provisionalization
- 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
- 1 Dec 2018to 1 May 2020
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 years old
- Good medical and psychological health
- Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients required periodontal treatment (non-surgical and/or surgical), this was arranged outside the study protocol and completed at least 30 days prior to the enrolment
- Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
- Willingness to sign the informed consent form
Who cannot join
- Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation;
- Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within 1 month before baseline visit;
- Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg);
- HIV or Hepatitis;
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- Alcoholism or chronic drug abuse;
- Heavy smokers (>10/cigarettes per day);
- Lack of adequate primary stability at implant insertion that enables immediate provisionalization (insertion torque ca 30 Ncm).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Hany ElNahass, PHD, Nahass77@gmail.com
About this study
Official title: Comparison of Peri-implant Soft Tissue Esthetics Around Single Delayed Implant With Immediate Provisionalization Placed in The Esthetic Zone With and Without Using Subepithelial Connective Tissue Graft: A Randomized Clinical Trial
The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.
Read the detailed description
To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics along with immediate temporization to immediate temporization only.
Population (P): patients with a single missing tooth in the esthetic zone Intervention (I): Delayed implant placement with immediate temporization and subepithelial connective tissue graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome: Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical trial
- Being tested
- delayed implant with immediate provisionaliztion and soft tissue graft, delayed implant placement with immediate provisionalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed implant with immediate provisionaliztion and soft tissue graftProcedure or surgery
delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal
delayed implant placement with immediate provisionalizationProcedure or surgery
delayed implant placement with immediate provisionalization
| Study group | Role | What they receive |
|---|---|---|
| Delayed implant placement with immediate provisionalization | Active comparator | Single delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery Receives: Procedure: delayed implant with immediate provisionaliztion and soft tissue graft |
| Implant with immediate temporization and soft tissue graft | Experimental | Single delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery Receives: Procedure: delayed implant placement with immediate provisionalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
Measured: 3 months post definitive prosthesis
Secondary outcomes (3)
Patient satisfaction by Visual analogue scale (VAS)
Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled "much less than natural teeth" which is marked by zero and the left anchor labeled "much more" which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line.
Measured: 3 months post definitive
Buccal peri-implant soft tissue thickness
the soft tissue thickness buccal to the implant by using an anesthesia needle and digital caliper
Measured: 3 months post definitive
Recession of the buccal peri-implant mucosa
measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins.
Measured: 3 months post definitive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
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 Temporization and Soft Tissue Augmentation Around Delayed ImplantsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Osama Abdelwahab Megahed, Cairo University
- Investigators
- Azza Ezz AlArab, PHD, Study chair, Professor in the department of Oral Medicine and Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770975
- Sponsor's protocol ID
- Dinaosamaperio
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelwahab D, Ezz AlArab A, El Nahass H. Soft tissue esthetics around immediately provisionalized delayed implants with and without connective tissue graft: A randomized clinical trial pilot study. Clin Implant Dent Relat Res. 2023 Feb;25(1):11-22. doi: 10.1111/cid.13168. Epub 2022 Dec 29.
PubMed 36579756
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peri-implant Soft Tissue Esthetics Around Single Delayed Implant With Immediate Provisionalization Placed in The Esthetic Zone With and Without Using Subepithelial Connective Tissue Graft: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03770975
- Acronym / sponsor ID
- Dinaosamaperio
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 10 Dec 2018 (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 aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.
Detailed description
To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics along with immediate temporization to immediate temporization only.
Population (P): patients with a single missing tooth in the esthetic zone Intervention (I): Delayed implant placement with immediate temporization and subepithelial connective tissue graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome: Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed implant placement with immediate provisionalization | Active comparator | Procedure: delayed implant with immediate provisionaliztion and soft tissue graftSingle delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery |
| Implant with immediate temporization and soft tissue graft | Experimental | Procedure: delayed implant placement with immediate provisionalizationSingle delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Good medical and psychological health
- Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients required periodontal treatment (non-surgical and/or surgical), this was arranged outside the study protocol and completed at least 30 days prior to the enrolment
- Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
- Willingness to sign the informed consent form
Key exclusion criteria (8 listed)
- Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation;
- Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within 1 month before baseline visit;
- Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg);
- HIV or Hepatitis;
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
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 |
|---|---|---|
| delayed implant with immediate provisionaliztion and soft tissue graftdelayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal | Procedure or surgery | Delayed implant placement with immediate provisionalization |
| delayed implant placement with immediate provisionalizationdelayed implant placement with immediate provisionalization | Procedure or surgery | Implant with immediate temporization and soft tissue graft |
Primary outcome
Pink Esthetic Score
Time frame: 3 months post definitive prosthesis
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
3 secondary outcomes
Patient satisfaction by Visual analogue scale (VAS)
Time frame: 3 months post definitive
Buccal peri-implant soft tissue thickness
Time frame: 3 months post definitive
Recession of the buccal peri-implant mucosa
Time frame: 3 months post definitive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Derived from this study: PubMed 36579756Abdelwahab D, Ezz AlArab A, El Nahass H. Soft tissue esthetics around immediately provisionalized delayed implants with and without connective tissue graft: A randomized clinical trial pilot study. Clin Implant Dent Relat Res. 2023 Feb;25(1):11-22. doi: 10.1111/cid.13168. Epub 2022 Dec 29.
- 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.
Azza Ezz AlArab, PHD study chair
Professor in the department of Oral Medicine and Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing delayed implant with immediate provisionaliztion and soft tissue graft and delayed implant placement with immediate provisionalization in people with Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants, 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 5 inclusion and 8 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 10 Dec 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dina Osama, Bachelor (01003808409 ext. 002, dina.osama@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (time frame: 3 months post definitive prosthesis). 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 NCT03770975, 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 10 Dec 2018.