Soft Tissue AugmentationPhase 4NCT06091605
Evaluation of Omega Roll Envelope Flap for Soft Tissue Augmentation Around Osseointegrated Dental Implants
A Phase 4 study testing Soft tissue augmentation around dental implants. in people with Soft Tissue Augmentation and Dental Implants, run by Ain Shams University.
Trial summary
Abstract Statement of the problem: Peri-implant soft-tissue augmentation procedures can be broadly divided into two groups, depending on their primary therapeutic objective: (1) Peri-implant soft-tissue phenotype modification and (2) Treatment of peri-implant marginal mucosa defects (PMMDs), also known as peri-implant… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation, Dental Implants
- What is being tested?
- Soft tissue augmentation around dental implants.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 May 2025
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically free patients (American Society of Anesthesiologists (ASA) I. Patients between 18 - 50 years of both genders and able to understand the nature of the proposed surgery and to sign the informed consent. Ability to comply with the study related procedures such as maintaining good oral hygiene and attending all follow-up scheduled appointments. Patients who complained of a single missing tooth bounded with two adjacent natural sound teeth diagnosed with clinical periodontal health. Necessity for soft tissue augmentation in a single tooth gap determined by a concavity that was present in the edentulous area or tissues with thin biotype being ≤2 mm or with inadequate width of ≤4mm. Adequate bone width for implant placement without need for bone augmentation (confirmed by a single pre-operative cone-beam computed tomography) (CBCT).
Who cannot join
- Previous soft tissue augmentation in the area. Need for major soft or hard tissue augmentation procedures. Smokers. Patients taking medications that might affect the healing of soft and hard peri-implant tissues.
Trial locations and contacts
No sites are listed yet.
Mohamed S Abd El Aziz contact
About this study
Abstract Statement of the problem: Peri-implant soft-tissue augmentation procedures can be broadly divided into two groups, depending on their primary therapeutic objective: (1) Peri-implant soft-tissue phenotype modification and (2) Treatment of peri-implant marginal mucosa defects (PMMDs), also known as peri-implant soft-tissue dehiscences.
Aim of the study: The aim of this study will be to evaluate the efficacy of the Omega roll envelope flap (OREF) technique compared to the conventional envelope split-thickness flap technique combined with an autogenous connective tissue graft, in enhancing Peri-implant soft tissue phenotype defined by the gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant.
Read the detailed description
Materials and Methods: 24 patients complaining of a single missing tooth in the with adjacent intact natural teeth and demanding replacing it with the best possible esthetics will be enrolled and recruited from the outpatient clinic, Faculty of Dentistry, Ain Shams University according to eligibility criteria. They will be randomly allocated to two equal groups. Group A (test group, n=12) will have a single implant placed after receiving non-surgical periodontal therapy and then after 12 weeks at the uncovering of the implant and placement of healing abutment, an Omega roll envelope flap (OREF) technique will be carried out for soft tissue augmentation, while Group B (control group, n=12) same procedures will be done but, soft tissue augmentation will be done by an envelope split-thickness flap combined with a sub-epithelial connective tissue graft. After 3 and 6 months Peri-implant soft tissue phenotype defined by gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant will be clinically assessed (1ry outcome). The 2ry outcomes will include comparing between the probing depth and clinical attachment level. Postoperative pain and swelling will be recorded by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be blinded. Data collected will be tabulated and statistically analyzed.
- Conditions
- Soft Tissue Augmentation, Dental Implants
- Being tested
- Soft tissue augmentation around dental implants.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation around dental implants.Procedure or surgery
Also called Soft tissue augmentation around dental implants using Envelope flap combined with a sub-epithelial connective tissue graft.
Soft tissue augmentation around dental implants using Omega roll envelope flap (OREF) technique.
| Study group | Role | What they receive |
|---|---|---|
| Omega roll envelope flap (OREF) technique | Experimental | Patients will undergo peri-implant soft tissue augmentation procedures accompanied by the placement of healing abutments at the uncovering of the inserted osseo-integrated implants, 12 weeks after the initial stage of implant placement.
Omega roll envelope flap (OREF) technique will be done around the placed healing abutment, then suturing will be done. Receives: Procedure: Soft tissue augmentation around dental implants. |
| Envelope flap combined with a sub-epithelial connective tissue graft | Active comparator | Patients will undergo peri-implant soft tissue augmentation procedures accompanied by the placement of healing abutments at the uncovering of the inserted osseo-integrated implants, 12 weeks after the initial stage of implant placement.
An envelope split thickness flap will be made at the concerned implant site and a connective tissue graft will be harvested from the tuberosity and then adapted to the placed healing abutment at the surgical site and suturing will be done. Receives: Procedure: Soft tissue augmentation around dental implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant soft tissue phenotype
Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper,
Measured: Baseline, 3 Months & 6 Months
Secondary outcomes (6)
Postoperative pain
Numerical rating scale (Visual analog scale) Scores (0-10)
Measured: At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient)
Postoperative swelling
Numerical rating scale (Visual analog scale) Scores (0-10)
Measured: At the day of procedure and for 7 days (registered before bedtime at specific time point for each patient)
Implant soft tissue deficiency Esthetic Score (IDES)
Scores of:
- Soft Tissue Margin (STM) (0-5): 0= No improvement of the PSTD and 5=Complete coverage of the metallic components with the mucosal margin at the same level of the homologous tooth.
- Peri-implant papillae height (PPH) (0-3): 0=Both papillae are more apical than the healthiest papilla tip of the homologous tooth and 3=Both papillae are at the same level (or more coronal) of the healthiest papilla tip of the homologous tooth.
- Peri-implant Mucosa (PMC) (0-1): 0=Distinguishable from the adjacent soft tissue and 1=Not distinguishable from the adjacent soft tissue.
- Peri-implant Mucosa Appearance (PMA) (0-1): 0=Presence of at least one of these conditions: scar tissue, MGJ not-aligned, tissue volume too thin or too thick compared to the adjacent soft tissue or tissue texture not similar to the adjacent soft tissue and 1=Absence of scar tissue, MGJ well aligned, tissue volume in line with the adjacent soft tissue or tissue texture similar to the adjacent soft tissue.
Measured: At 6 months
Esthetic satisfaction
Numerical rating scale (Visual analog scale) Scores (0-10)
Measured: At 3 and 6 months
Probing depth
Using UNC-15 Periodontal Probe
Measured: Baseline, 3 Months & 6 Months
Clinical Attachment Level (CAL)
Using UNC-15 Periodontal Probe 0mm= Normal <1-2mm= Stage 1 Periodontitis <3-4mm= Stage 2 Periodontitis >5mm= Stage 3 and 4 Perodontitis
Measured: Baseline, 3 Months & 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AugmentationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Saeed Abd El Aziz, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091605
- Sponsor's protocol ID
- FD-ASU1255
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Omega Roll Envelope Flap for Soft Tissue Augmentation Around Osseointegrated Dental Implants
- ClinicalTrials.gov ID
- NCT06091605
- Acronym / sponsor ID
- FD-ASU1255
- Conditions
- Soft Tissue Augmentation, Dental Implants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Oct 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.
Abstract Statement of the problem: Peri-implant soft-tissue augmentation procedures can be broadly divided into two groups, depending on their primary therapeutic objective: (1) Peri-implant soft-tissue phenotype modification and (2) Treatment of peri-implant marginal mucosa defects (PMMDs), also known as peri-implant soft-tissue dehiscences.
Aim of the study: The aim of this study will be to evaluate the efficacy of the Omega roll envelope flap (OREF) technique compared to the conventional envelope split-thickness flap technique combined with an autogenous connective tissue graft, in enhancing Peri-implant soft tissue phenotype defined by the gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant.
Detailed description
Materials and Methods: 24 patients complaining of a single missing tooth in the with adjacent intact natural teeth and demanding replacing it with the best possible esthetics will be enrolled and recruited from the outpatient clinic, Faculty of Dentistry, Ain Shams University according to eligibility criteria. They will be randomly allocated to two equal groups. Group A (test group, n=12) will have a single implant placed after receiving non-surgical periodontal therapy and then after 12 weeks at the uncovering of the implant and placement of healing abutment, an Omega roll envelope flap (OREF) technique will be carried out for soft tissue augmentation, while Group B (control group, n=12) same procedures will be done but, soft tissue augmentation will be done by an envelope split-thickness flap combined with a sub-epithelial connective tissue graft. After 3 and 6 months Peri-implant soft tissue phenotype defined by gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant will be clinically assessed (1ry outcome). The 2ry outcomes will include comparing between the probing depth and clinical attachment level. Postoperative pain and swelling will be recorded by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be blinded. Data collected will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega roll envelope flap (OREF) technique | Experimental | Procedure: Soft tissue augmentation around dental implants.Patients will undergo peri-implant soft tissue augmentation procedures accompanied by the placement of healing abutments at the uncovering of the inserted osseo-integrated implants, 12 weeks after the initial stage of implant placement. Omega roll envelope flap (OREF) technique will be done around the placed healing abutment, then suturing will be done. |
| Envelope flap combined with a sub-epithelial connective tissue graft | Active comparator | Procedure: Soft tissue augmentation around dental implants.Patients will undergo peri-implant soft tissue augmentation procedures accompanied by the placement of healing abutments at the uncovering of the inserted osseo-integrated implants, 12 weeks after the initial stage of implant placement. An envelope split thickness flap will be made at the concerned implant site and a connective tissue graft will be harvested from the tuberosity and then adapted to the placed healing abutment at the surgical site and suturing will be done. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically free patients (American Society of Anesthesiologists (ASA) I. Patients between 18 - 50 years of both genders and able to understand the nature of the proposed surgery and to sign the informed consent. Ability to comply with the study related procedures such as maintaining good oral hygiene and attending all follow-up scheduled appointments. Patients who complained of a single missing tooth bounded with two adjacent natural sound teeth diagnosed with clinical periodontal health. Necessity for soft tissue augmentation in a single tooth gap determined by a concavity that was present in the edentulous area or tissues with thin biotype being ≤2 mm or with inadequate width of ≤4mm. Adequate bone width for implant placement without need for bone augmentation (confirmed by a single pre-operative cone-beam computed tomography) (CBCT).
Key exclusion criteria (1 listed)
- Previous soft tissue augmentation in the area. Need for major soft or hard tissue augmentation procedures. Smokers. Patients taking medications that might affect the healing of soft and hard peri-implant tissues.
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 |
|---|---|---|
| Soft tissue augmentation around dental implants.Also: Soft tissue augmentation around dental implants using Envelope flap combined with a sub-epithelial connective tissue graft.Soft tissue augmentation around dental implants using Omega roll envelope flap (OREF) technique. | Procedure or surgery | Envelope flap combined with a sub-epithelial connective tissue graft, Omega roll envelope flap (OREF) technique |
Primary outcome
Peri-implant soft tissue phenotype
Time frame: Baseline, 3 Months & 6 Months
Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper,
6 secondary outcomes
Postoperative pain
Time frame: At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient)
Postoperative swelling
Time frame: At the day of procedure and for 7 days (registered before bedtime at specific time point for each patient)
Implant soft tissue deficiency Esthetic Score (IDES)
Time frame: At 6 months
Esthetic satisfaction
Time frame: At 3 and 6 months
Probing depth
Time frame: Baseline, 3 Months & 6 Months
Clinical Attachment Level (CAL)
Time frame: Baseline, 3 Months & 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed S Abd El Aziz contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soft tissue augmentation around dental implants. in people with Soft Tissue Augmentation and Dental Implants, run by Ain Shams University.
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 1 inclusion and 1 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Amr M Saeed, Msc of Perio. (01111304015 ext. 002-, amrsaeed92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant soft tissue phenotype (time frame: Baseline, 3 Months & 6 Months). 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 19 Oct 2023.