Implant Tissue FailureFascia LataNCT04679922
Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant Mucosal Thickness Enhancement.
A study testing Soft Tissue Enhancement around dental implant in people with Implant Tissue Failure, run by Mohamed Hamdy Helal at 1 site in Egypt.
Trial summary
The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults . Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Implant Tissue Failure
- What is being tested?
- Soft Tissue Enhancement around dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2019to 18 Nov 2020
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to maintain good oral hygiene as evidenced in recall visits. Aged 30 to 55 years. Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness).
Who cannot join
- Uncontrolled diabetes mellitus. Females who were pregnant, or attempting to become pregnant, and nursing mothers.
- Acute infection in the area intended for implant placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant
The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .
Read the detailed description
The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .
The hypothesis of the study is that a similar gain in peri implant mucosal thicknesses will be obtained in sites treated by either a sub epithelial connective tissue graft or a newly developed fascia lata allograft in clinically and histologically in human.
The objective of this study will be to evaluate the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or human Fascia Lata Allograft placed simultaneously with dental implant placement.
Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Participants will be randomized to the control (simultaneous SCTGs) or test (simultaneous FLA) group.
- Conditions
- Implant Tissue Failure
- Being tested
- Soft Tissue Enhancement around dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue Enhancement around dental implantProcedure or surgery
Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Sixteen sites that were met the subsequent inclusion criteria were eligible to contribute in our study were classified randomly by the sealed envelope technique into two treatment groups, 8 sites in each group. Group I (Control Group): Autogenous SCTGs harvested from the palate +dental implants *. Group II (Experimental Group): FLA **+dental implants. The allocation was withheld from the surgeon (M.H.) until just before the surgical appointment. The clinical examiner (M.S.) was masked to the treatment group for the extent of the study.Three months after implantation, the sites were located, and the thickness of the mucosa will be evaluated using the customized stent. The operculectomy will be performed following the method of Flatebo et al.,22 collecting biopsy specimens of almost constant quality and evaluating clinical thickness without mucosal distortions
| Study group | Role | What they receive |
|---|---|---|
| Peri Implant mucosal thickness connective tissue graft | Active comparator | Not described Receives: Procedure: Soft Tissue Enhancement around dental implant |
| Peri Implant mucosal thickness fascia lata graft | Experimental | Not described Receives: Procedure: Soft Tissue Enhancement around dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-Implant Mucosal Thickness
The primary outcome of interest will be to measure changes (in mm) in horizontal PMT on the buccal aspect of the edentulous alveolar ridge from baseline (implant placement and grafting) to (4, 8, 12, and 24 weeks) of post-surgical healing.
Measured: Measure changes in mucosal thickness around dental implant at base line and after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start10 Dec 2019
- Primary completion20 Jul 2020
- Study completion18 Nov 2020
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 Implant Tissue FailureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Hamdy Helal
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Mohamed Hamdy Helal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679922
- Sponsor's protocol ID
- OMPDR-07-19-5
- Acronym
- Fascia Lata
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helal MH, Elguindy HM, Ghoraba SF, Shoukheba MY. Fascia lata allograft versus subepithelial connective tissue graft for peri-implant mucosal augmentation at implant placement: a randomized pilot clinical trial. BMC Oral Health. 2026 Jun 23;26(1):1123. doi: 10.1186/s12903-026-08829-y.
PubMed 42337524
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant
- ClinicalTrials.gov ID
- NCT04679922
- Acronym / sponsor ID
- Fascia Lata / OMPDR-07-19-5
- Conditions
- Implant Tissue Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mohamed Hamdy HelalUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 22 Dec 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 aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .
Detailed description
The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .
The hypothesis of the study is that a similar gain in peri implant mucosal thicknesses will be obtained in sites treated by either a sub epithelial connective tissue graft or a newly developed fascia lata allograft in clinically and histologically in human.
The objective of this study will be to evaluate the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or human Fascia Lata Allograft placed simultaneously with dental implant placement.
Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Participants will be randomized to the control (simultaneous SCTGs) or test (simultaneous FLA) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri Implant mucosal thickness connective tissue graft | Active comparator | Procedure: Soft Tissue Enhancement around dental implant |
| Peri Implant mucosal thickness fascia lata graft | Experimental | Procedure: Soft Tissue Enhancement around dental implant |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ability to maintain good oral hygiene as evidenced in recall visits. Aged 30 to 55 years. Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness).
Key exclusion criteria (2 listed)
- Uncontrolled diabetes mellitus. Females who were pregnant, or attempting to become pregnant, and nursing mothers.
- Acute infection in the area intended for implant placement.
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 Enhancement around dental implantSixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Sixteen sites that were met the subsequent inclusion criteria were eligible to contribute in our study were classified randomly by the sealed envelope technique into two treatment groups, 8 sites in each group. Group I (Control Group): Autogenous SCTGs harvested from the palate +dental implants *. Group II (Experimental Group): FLA **+dental implants. The allocation was withheld from the surgeon (M.H.) until just before the surgical appointment. The clinical examiner (M.S.) was masked to the treatment group for the extent of the study.Three months after implantation, the sites were located, and the thickness of the mucosa will be evaluated using the customized stent. The operculectomy will be performed following the method of Flatebo et al.,22 collecting biopsy specimens of almost constant quality and evaluating clinical thickness without mucosal distortions | Procedure or surgery | Peri Implant mucosal thickness connective tissue graft, Peri Implant mucosal thickness fascia lata graft |
Primary outcome
Peri-Implant Mucosal Thickness
Time frame: Measure changes in mucosal thickness around dental implant at base line and after 6 months.
The primary outcome of interest will be to measure changes (in mm) in horizontal PMT on the buccal aspect of the edentulous alveolar ridge from baseline (implant placement and grafting) to (4, 8, 12, and 24 weeks) of post-surgical healing.
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 22 Dec 2020.
- Derived from this study: PubMed 42337524Helal MH, Elguindy HM, Ghoraba SF, Shoukheba MY. Fascia lata allograft versus subepithelial connective tissue graft for peri-implant mucosal augmentation at implant placement: a randomized pilot clinical trial. BMC Oral Health. 2026 Jun 23;26(1):1123. doi: 10.1186/s12903-026-08829-y.
- Individual participant dataSharing planned: No
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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 Soft Tissue Enhancement around dental implant in people with Implant Tissue Failure, run by Mohamed Hamdy Helal 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 1 inclusion and 2 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 22 Dec 2020. 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?
Peri-Implant Mucosal Thickness (time frame: Measure changes in mucosal thickness around dental implant at base line and after 6 months.). 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 NCT04679922, 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 22 Dec 2020.