Soft Tissue AugmentationNCT03425864
PES After Soft Tissue Augmentation Using CTG Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
A study testing connective tissue graft and immediate implant in people with Soft Tissue Augmentation, run by Nada Farouk Hasan Abd El-Aziz at 1 site in Egypt.
Trial summary
The goal of the present study is to compare the esthetic result and stability of gingival tissue over the immediate implant only and immediate implant with connective tissue in patients with single non-restorable tooth in the esthetic zone. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation
- What is being tested?
- connective tissue graft and immediate implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2017to 13 Oct 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-restorable teeth located within the maxillary anterior area and premolars. Age ranged between 20 to 50 years old. Sufficient vertical inter-arch space upon centric occlusion. Patients with good oral hygiene. Intact labial/buccal bone plate.
- 10. a. Inclusion criteria
- 1. Age: 20-50. 2. Patients with single non-restorable teeth in anterior or premolar area. 3. "Patients with adequate bone volume for the dental implant procedure". 5. Patients who are compliant to oral hygiene measures. 6. Patient consent approval and signing.
- 10. b. Exclusion criteria:
- Patients with any systemic disease that could affect normal healing of tissue and predictable outcome.
- Patients with any habits that might affect osseointegration, such as heavy smoking and alcoholism.
Show all 10Show fewer
- Pregnant women.
- Patients with untreated periodontal disease or the presence of pathologic condition at implant site.
- Patients with Parafunctional habits that produce overload on the implant such as bruxism and clenching.
- Shallow palate.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pink Esthetic Score Evaluation After Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
The goal of the present study is to compare the esthetic result and stability of gingival tissue over the immediate implant only and immediate implant with connective tissue in patients with single non-restorable tooth in the esthetic zone. The main null hypothesis to be tested is that the addition of SCTG to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.
Read the detailed description
Implant became a treatment modality for replacing missing or non-restorable teeth, providing clinical success rate and esthetic outcome. (1) In esthetic zone the main goal is not only the preservation of function but also the preservation of the esthetics. The esthetic outcome of implant supported restoration depend on the soft tissue volume and the soft tissue contour. (2) The placement of immediate implant after tooth extraction was proved as a very high success rate treatment modality. It provided several advantages such as reduction of the time between tooth extraction and the placement of prosthesis, reduction of the number of surgical treatments (3) and increase osteointegration between bone and implant surface (4).
Considering the survival rate of immediate implantation versus delayed implantation there is no significant difference with an overall success rate of 99.6%, it is just considered as a successful treatment modality, based on 802 implants (5).
On the other hand disadvantage related to esthetic outcome has been reported, showing facial gingival recession following the first year of function due to labial bone plate resorption. (6, 2).
A systematic review by Sanz et al.,(2012) compared the reduction of bone height and bone width between two groups the control group was delayed implant placement and the studied group was immediate implant placement and the mean difference between groups was of 13.11% (95% CI: from 3.83 to 22.4; P = 0.057) and 19.85% (95% CI: from 13.85 to 25.81)respectively, concluding that the early placement of dental implants after tooth extraction offers advantages in terms of soft and hard tissue preservation, compared with delayed implant placement , which affect the aesthetic (7 ) As a sequence of dimensional ridge alterations that occur following tooth extraction many studies reported a recession of marginal peri-implant mucosa, which affect the aesthetic outcome (8, 9, and 10).
A study made by Migliorati et al., (2015) between two groups, the control group (immediate loading implant treated without raising a flap) and the test group (immediate loaded implant treated with sub-epithelial connective tissue graft (SCTG) using the tunnel technique in the labial area) Both groups (47 implants) received deproteinized bovine bone minerals and implants were successfully integrated with a follow up period 2-year examination . Moreover the mean recession in the control group was 0.71mm (17.58%), one third of the control group reported recession >1mm, and mean pink aesthetic score (PES) was 6.65, resulting in bad aesthetic. The test group showed an increase of the keratinized mucosa (KM) with a mean of 34.29% (0.5mm) and a mean recession of 0.2mm (10.01%), only one case (4%) showed recession >1mm and the mean PES was 8. The thickening of soft tissue by the addition of SCTG, lead to compensation and maintenance of the loss of bone volume in the labial area (11).
The addition of sub epithelial connective tissue graft (SCTG) to the immediate implant was suggested for facial gingival biotype conversation. It was proved to be successful in preserving soft tissue levels. (12)
A systematic review was made to investigate if the addition of SCTG overcome the disadvantage of placement of immediate implant only or not, but unfortunately the included studies had different techniques and the number of the patients in those studies was few thus further RCT was necessary (13).
- Conditions
- Soft Tissue Augmentation
- Being tested
- connective tissue graft, immediate implant
- Keywords
- immediate implant, connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graftProcedure or surgery
Also called subepithelial connective tissue graft
patient will receive immediate implant and connective tissue graft
immediate implantDevice
Also called post extraction dental implant
patient will receive immediate implant with connective tissue graft.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant | Other | patient will receive immediate implant alone. Receives: Device: immediate implant |
| immediate implant with connective tissue graft | Active comparator | patient will receive immediate implant and connective tissue gaft Receives: Procedure: connective tissue graft; Device: immediate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score
evaluation of pink esthetic score around immediate implant only in esthetic zone around immediate implant with connective tissue graft in esthetic zone
Measured: should be measured after 8 months below implant and graft placement
Secondary outcomes (2)
tissue piotype
It is measured by penetrating the gingiva perpendicular to the tooth with the periodontal probe down to the bone after giving local anesthesia to determine the thickness of the tissue and apical to the gingival margin at the vertical bisecting midline with reference to the cementoenamel junction of adjacent teeth.
Measured: should be measured after 6 months below implant and graft placement
width of keratinized gingiva
It is recorded as the distance from the mucogingival junction (MGJ) to the free gingival margin of the related tooth by graduated periodontal probe.
Measured: should be measured after 6 months below implant and graft placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start11 Jul 2017
- Primary completion13 Sep 2020
- Study completion13 Oct 2020
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.
- 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
- Eligible patients will be randomized using sequence generation program (Random.org in equal proportions between control group (immediate implant alone) and study group (immediate implant covered with sub-epithelial connective tissue graft with full coverage technique).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nada Farouk Hasan Abd El-Aziz
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Nada Farouk Hasan Abd El-Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425864
- Sponsor's protocol ID
- 2010
- Status last verified
- Oct 2020
- First submitted
- 26 Jan 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pink Esthetic Score Evaluation After Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
- ClinicalTrials.gov ID
- NCT03425864
- Acronym / sponsor ID
- 2010
- Conditions
- Soft Tissue Augmentation
- Keywords
- immediate implant, connective tissue graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nada Farouk Hasan Abd El-AzizUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 13 Sep 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 8 Feb 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 goal of the present study is to compare the esthetic result and stability of gingival tissue over the immediate implant only and immediate implant with connective tissue in patients with single non-restorable tooth in the esthetic zone. The main null hypothesis to be tested is that the addition of SCTG to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.
Detailed description
Implant became a treatment modality for replacing missing or non-restorable teeth, providing clinical success rate and esthetic outcome. (1) In esthetic zone the main goal is not only the preservation of function but also the preservation of the esthetics. The esthetic outcome of implant supported restoration depend on the soft tissue volume and the soft tissue contour. (2) The placement of immediate implant after tooth extraction was proved as a very high success rate treatment modality. It provided several advantages such as reduction of the time between tooth extraction and the placement of prosthesis, reduction of the number of surgical treatments (3) and increase osteointegration between bone and implant surface (4).
Considering the survival rate of immediate implantation versus delayed implantation there is no significant difference with an overall success rate of 99.6%, it is just considered as a successful treatment modality, based on 802 implants (5).
On the other hand disadvantage related to esthetic outcome has been reported, showing facial gingival recession following the first year of function due to labial bone plate resorption. (6, 2).
A systematic review by Sanz et al.,(2012) compared the reduction of bone height and bone width between two groups the control group was delayed implant placement and the studied group was immediate implant placement and the mean difference between groups was of 13.11% (95% CI: from 3.83 to 22.4; P = 0.057) and 19.85% (95% CI: from 13.85 to 25.81)respectively, concluding that the early placement of dental implants after tooth extraction offers advantages in terms of soft and hard tissue preservation, compared with delayed implant placement , which affect the aesthetic (7 ) As a sequence of dimensional ridge alterations that occur following tooth extraction many studies reported a recession of marginal peri-implant mucosa, which affect the aesthetic outcome (8, 9, and 10).
A study made by Migliorati et al., (2015) between two groups, the control group (immediate loading implant treated without raising a flap) and the test group (immediate loaded implant treated with sub-epithelial connective tissue graft (SCTG) using the tunnel technique in the labial area) Both groups (47 implants) received deproteinized bovine bone minerals and implants were successfully integrated with a follow up period 2-year examination . Moreover the mean recession in the control group was 0.71mm (17.58%), one third of the control group reported recession >1mm, and mean pink aesthetic score (PES) was 6.65, resulting in bad aesthetic. The test group showed an increase of the keratinized mucosa (KM) with a mean of 34.29% (0.5mm) and a mean recession of 0.2mm (10.01%), only one case (4%) showed recession >1mm and the mean PES was 8. The thickening of soft tissue by the addition of SCTG, lead to compensation and maintenance of the loss of bone volume in the labial area (11).
The addition of sub epithelial connective tissue graft (SCTG) to the immediate implant was suggested for facial gingival biotype conversation. It was proved to be successful in preserving soft tissue levels. (12)
A systematic review was made to investigate if the addition of SCTG overcome the disadvantage of placement of immediate implant only or not, but unfortunately the included studies had different techniques and the number of the patients in those studies was few thus further RCT was necessary (13).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized using sequence generation program (Random.org in equal proportions between control group (immediate implant alone) and study group (immediate implant covered with sub-epithelial connective tissue graft with full coverage technique).
| Arm | Type | Receives |
|---|---|---|
| immediate implant | Other | Device: immediate implantpatient will receive immediate implant alone. |
| immediate implant with connective tissue graft | Active comparator | Procedure: connective tissue graft, Device: immediate implantpatient will receive immediate implant and connective tissue gaft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Non-restorable teeth located within the maxillary anterior area and premolars. Age ranged between 20 to 50 years old. Sufficient vertical inter-arch space upon centric occlusion. Patients with good oral hygiene. Intact labial/buccal bone plate.
- 10. a. Inclusion criteria
- 1. Age: 20-50. 2. Patients with single non-restorable teeth in anterior or premolar area. 3. "Patients with adequate bone volume for the dental implant procedure". 5. Patients who are compliant to oral hygiene measures. 6. Patient consent approval and signing.
- Patients with any systemic disease that could affect normal healing of tissue and predictable outcome.
- Patients with any habits that might affect osseointegration, such as heavy smoking and alcoholism.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| connective tissue graftAlso: subepithelial connective tissue graftpatient will receive immediate implant and connective tissue graft | Procedure or surgery | immediate implant with connective tissue graft |
| immediate implantAlso: post extraction dental implantpatient will receive immediate implant with connective tissue graft. | Device | immediate implant, immediate implant with connective tissue graft |
Primary outcome
pink esthetic score
Time frame: should be measured after 8 months below implant and graft placement
evaluation of pink esthetic score around immediate implant only in esthetic zone around immediate implant with connective tissue graft in esthetic zone
2 secondary outcomes
tissue piotype
Time frame: should be measured after 6 months below implant and graft placement
width of keratinized gingiva
Time frame: should be measured after 6 months below implant and graft placement
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 18 Jun 2021.
- 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 connective tissue graft and immediate implant in people with Soft Tissue Augmentation, run by Nada Farouk Hasan Abd El-Aziz 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 10 inclusion and 0 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 18 Jun 2021. 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?
pink esthetic score (time frame: should be measured after 8 months below implant and graft placement). 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 18 Jun 2021.