Hopeless Tooth in Esthetic ZoneNCT06728696
Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor
A study testing Immediate implant with with dual zone technique using concentrated growth factor graft. and Immediate implant with dual zone technique using connective tissue graft. in people with Hopeless Tooth in Esthetic Zone and Loss of Soft and Hard Tissue Around Implant, run by Ain Shams University at 1 site in Egypt.
Trial summary
Tooth extraction not only alters the bony architecture of the alveolar ridge, but it also has an impact on the surrounding soft tissues. Post-extraction recovery of both hard and soft tissues occurs uneventfully, resulting in horizontal and vertical tissue loss, affecting prosthetic rehabilitation with dental implants… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant, Immediate Implant Placement
- What is being tested?
- Immediate implant with with dual zone technique using concentrated growth factor graft. and Immediate implant with dual zone technique using connective tissue graft.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 15 Jun 2025
- 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
- Systemically (medically) free individuals were recruited for the present study according to the modified Burkett's health history questionnaire, ASA.
- Males and females with age range 20 - 50.
- Patients having a history of hopeless tooth in esthetic zone (Anteriors/Premolars) indicated for extraction and immediate implant placement.
- Patients who are cooperative and maintain proper oral hygiene.
- Intact interproximal and palatal bone extending at least 6 mm apically, with sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque).
Who cannot join
- Heavy smokers. 20
- Patients who exhibit parafunctional occlusal habits 21
- Pregnant ladies or lactating mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor (A Randomized Clinical Trial)
Tooth extraction not only alters the bony architecture of the alveolar ridge, but it also has an impact on the surrounding soft tissues. Post-extraction recovery of both hard and soft tissues occurs uneventfully, resulting in horizontal and vertical tissue loss, affecting prosthetic rehabilitation with dental implants or tooth-supported prosthesis.
Aim of the study:
Read more
The aim of this study is to evaluate volumetric soft tissue alterations as well as clinical, radiographic, and esthetic outcomes in dual zone technique (DZ) using CTG (Connective Tissue Graft) versus CGF (Concentrated Growth Factor) Graft following maxillary IIP (Immediate Implant Placement) in the esthetic zone.
Materials and methods:
20 patients with hopeless teeth requiring extraction in maxillary esthetic zone and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain Shams University according to the inclusion criteria. They will be randomly allocated into two equal groups. Group I (n=17) immediate implant placement with dual zone technique using concentrated growth factor graft and group II (n=17) immediate implant placement with dual zone technique using connective tissue graft. Pink esthetic score (PES) was measured 6 months after the final crown placement. At the respective times radiographic CBCT measurements, volumetric analysis, and clinical measurements will be taken. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.
Read the detailed description
Maintaining the natural esthetic appearance, particularly in the esthetic zone, together with the volume and contour of the soft tissue in harmony with the surrounding teeth soft tissue, is believed to be critical. However, postponing implant placement until hard and soft tissues have fully healed usually necessitates additional surgical intervention steps, such as guided bone regeneration or ridge splitting, or implant placement in undesirable positions with a low esthetic appearance to overcome alveolar ridge resorption.
In clinical practice, immediate implant placement (IIP) in the esthetic zone has been regarded as an ongoing concern. Immediate implant placement (IIP) aims to minimize the duration of therapy overall, cost-effectiveness, and patient aesthetic expectations. However, the physician needs to be aware of potential risks and undesirable effects associated with this surgery, such as early implant loss and dimensional alterations in soft and hard tissues. Clinical research continues to advance to improve predictability and minimize the occurrence of undesirable consequences following IIP due to evolving patients\' esthetic demands and expectations.
Over the years, numerous surgical techniques have been proposed to preserve the soft and hard tissues in the esthetic zone. These techniques include proper 3D implant positioning, flapless approach, the addition of bone graft, the use of grafts containing growth factors such as concentrated growth factor (CGF) and platelet-rich fibrin (PRF) membranes, the application of connective tissue grafts (CTG), the socket shield technique, or the use of customized healing abutments. In order to offset the peri-implant tissue reduction, various treatments were also devised, including vestibular socket therapy, the dual-zone concept (DZ), and immediate dentoalveolar restoration.
From the above-mentioned approaches, Dual Zone technique was utilized in conjunction with CTG, and CGF graft were primarily advised for peri-implant soft tissue phenotypic preservation, stability, and health. The dual-zone (DZ) concept was developed to reduce the amount of buccal contour change at the extraction site while enhancing the thickness of the peri- implant soft tissues by filling the buccal gap with bone graft in two zones: the bone zone up to the crest of the socket bone and the soft tissue zone. To illustrate, graft particles are absorbed into tissues, increasing their thickness while also providing stability and maintaining soft tissue volume. As a result, the DZ concept aims to maintain the gingival contour while providing excellent soft tissue esthetics.
Connective tissue graft (CTG) and concentrated growth factor (CGF) graft are two commonly used materials for soft tissue augmentation in implant dentistry. CTG has a long history of success in improving soft tissue volume and quality around dental implants by forming a scaffold for cell migration and tissue regeneration. On the other hand, CGF, a newer autologous platelet concentrate rich in growth factors, has demonstrated promising results in stimulating tissue healing and regeneration, potentially outperforming standard graft materials.
To begin with, the success of utilizing CTG in covering exposed roots and increasing the width of the keratinized mucosa (WKM) prompted research into its usage in conjunction with immediate dental implants to improve their final esthetic effects. CTG is thought to be the gold standard for dimensional stability together with IIP in the esthetic zone. Furthermore, inserting CTG concurrently with IIP was claimed to reduce the likelihood of advanced mid-facial mucosal recession, prevent papillae loss, improve soft tissue contour, and reduce crestal bone resorption independent of tissue biotype. Other researches, however, argued that using CTG resulted in bone resorption and lost dimensional stability over time.
Platelets naturally produce Growth factors (GF) such as platelet-derived GF, Transforming GF (TGF)-β1 and β2 (TGF-β2), fibroblast GF, vascular endothelial GF, and insulin-like GF, which promote cell proliferation, matrix remodeling, and angiogenesis. Concentrated GF (CGF) is prepared by centrifuging venous blood, which concentrates platelets in a gel layer made up of a fibrin matrix rich in GFs and leukocytes. CGF operates by degranulating alpha granules in platelets, which play an important role in early wound healing. CGF has been shown to contain more GFs than other platelet-based preparations such as platelet rich fibrin (PRF) and platelet-rich plasma (PRP), and unlike PRP, CGF does not dissolve quickly after application. Furthermore, it was demonstrated that CGF may release GFs for at least 13 days.
CGF, first introduced by Sacco, has recently gained popularity. It is produced by centrifugation of venous blood, similar to PRF, but at a different speed (2400-2700 rpm) to separate cells in the venous blood, resulting in fibrin rich blocks that are much larger, denser, and richer in GF than common PRF. This demonstrates improved regeneration capacity and versatility when utilizing the fibrin-rich block. Furthermore, many studies showed that CGF has higher tensile strength, more growth factors, higher viscosity, and adhesive strength than PRF. As a result, surgeons can utilize CGF as a barrier membrane to speed up soft tissue healing or mix it with bone graft to expedite new bone growth.
Despite the growing interest in immediate dental implants and soft tissue augmentation techniques, limited comparative evidence exists regarding the efficacy of different grafting materials in the dual zone approach, particularly in the esthetic zone. Therefore, there is a need for well-designed randomized controlled clinical trials to evaluate the comparative effectiveness of CTG and CGF grafts in immediate dental implants using the dual zone technique.
This randomized clinical trial aims to address this gap in the literature by comparing the clinical and radiographic outcomes of immediate dental implants with dual zone technique using CTG versus CGF graft in the esthetic zone. By assessing parameters such as volumetric soft tissue alterations, pink esthetic score, clinical measurements, and radiographic bone dimensional changes, this study aims to provide evidence-based guidance for clinicians in selecting the most appropriate grafting material for achieving optimal esthetic outcomes in implant dentistry.
III. Research Question:
Are soft and hard tissue changes following immediate implant placement with dual zone concept and concentrated growth factor graft the same as dual zone concept and connective tissue graft on volumetric analysis, pink esthetic score, clinical, and radiographic measures at baseline, 6 months, and 1 year?
PICOTS Elements:
Patient/Problem :Patients with hopeless teeth requiring extraction in maxillary esthetic zone.
Intervention : Guided immediate implant placement with dual zone technique using concentrated growth factor graft Comparator : Guided immediate implant placement with dual zone technique using connective tissue graft Outcome: Volumetric analysis, Pink Esthetic Score (PES), clinical assessment and radiographic assessment. Time: Baseline and 6 months. Setting : Faculty of Dentistry, Ain Shams University.
- Conditions
- Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant, Immediate Implant Placement
- Being tested
- Immediate implant with with dual zone technique using concentrated growth factor graft., Immediate implant with dual zone technique using connective tissue graft.
- Keywords
- Immediate implant, Esthetic zone, Connective Tissue Graft, Concentrated Growth Factor Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant with with dual zone technique using concentrated growth factor graft.Procedure or surgery
In the test group, pouch technique + CGFG will be used. The CGFG will be packed in the split-thickness labial pouch between the labial bone plate and the overlying gingiva of the extraction socket. A convenient blood sample will be withdrawn from a peripheral venous blood from the patient using a specialized vacutaine. A standard, disposable, 10-ml non- anticoagulant tube and a matching centrifuge device was used. To prepare the CGFG, the centrifuge is accelerated for 30 seconds, then centrifuged at 2700 rpm for 2 minutes, 2400 rpm for 4 minutes, 2700 rpm for 4 minutes, and 3000 rpm for 3 minutes before being decelerated for 36 seconds to stop.
Immediate implant with dual zone technique using connective tissue graft.Procedure or surgery
Patients assigned to the control group will receive pouch technique + CTG. Following implant placement, a split-thickness labial pouch between the labial bone plate and the overlying gingiva of the extraction socket will be performed using 15c mini blade to allow for the placement of a CTG. The pouch preparation will be extended apical beyond the muco-gingival junction and to the neighboring teeth mesiodistally. The CTG will be harvested from the palate with a thickness of 1.5 mm using single-incision technique, which was done approximately 2-3 mm apical to the gingival margin of the maxillary teeth and parallel to the palatal long axis. A resorbable suture will be used to first pierce the labial mucosa along with the periosteum at an apical part, which then exits from the sulcus. Afterward, the CTG will be tucked in the pouch, labial to the suture, and held at a coronal area by using the needle to pierce it from its inner surface toward the labial soft tissue. The knot will then be se
| Study group | Role | What they receive |
|---|---|---|
| Group I (Test group): | Experimental | 17 patients with non-restorable tooth in the esthetic zone will receive atraumatic extraction followed by immediate implant placement with dual zone technique using concentrated growth factor graft. Receives: Procedure: Immediate implant with with dual zone technique using concentrated growth factor graft. |
| Group II (Control group): | Active comparator | 17 patients with non-restorable tooth in the esthetic zone will receive atraumatic extraction followed by immediate implant placement with dual zone technique using connective tissue graft. Receives: Procedure: Immediate implant with dual zone technique using connective tissue graft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric analysis
3D viewer soft tissue; mm changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin
Measured: Baseline and 6 months
Secondary outcomes (5)
Pink Esthetic Score
This scoring system has seven domains: mesial papilla, distal papilla, soft tissue level, contour, deficient alveolar process, soft tissue color, and texture. Each domain is rated from 0 to 2, with 2 being the highest score. The total PES is the sum of the seven domains' scores, which range from 0 to 14 (14 is the best score, signifying almost identical appearance to the contralateral natural tooth)
Measured: 6 months after final crown placement
Radiographic CBCT measurements
Amount of bone labial to implant, horizontal labio-palatal bone reduction, and crestal bone level changes.
Measured: Baseline and 6 months
Full-mouth plaque score
Measured pre-extraction and after 6 months 2 = visible deposit,
1 = deposit on probing, 0 = no deposit
Measured: Baseline and 6 months
Full-mouth bleeding score
score 0 -normal gingiva; score 1 -mild inflammation, slight change in color, slight oedema, no bleeding on probing; score 2 -moderate inflammation, redness, oedema, and glazing, bleeding on probing; score 3 -severe inflammation, marked redness and oedema, ulceration tendency to spontaneous bleeding.
Measured: Baseline and 6 months
Visual Analog Scale
Visual Analog Scale will be recorded by the patient 1, 3, and 7 days after the surgery.
The patients marked the pain perception in a non-numerical 10 cm line ranging from "no pain = 0" (left) to "very painful = 10" (right).
1-3 = mild pain 4-6 = moderate pain 7-10 = severe pain
Measured: 1, 3, and 7 days after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Jan 2025
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hopeless Tooth in Esthetic ZoneStudies 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
- Randomized, parallel design, two arms clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728696
- Sponsor's protocol ID
- 1383
- Status last verified
- Sep 2024
- First submitted
- 22 Nov 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06728696
- Acronym / sponsor ID
- 1383
- Conditions
- Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant, Immediate Implant Placement
- Keywords
- Immediate implant, Esthetic zone, Connective Tissue Graft, Concentrated Growth Factor Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 11 Dec 2024 (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.
Tooth extraction not only alters the bony architecture of the alveolar ridge, but it also has an impact on the surrounding soft tissues. Post-extraction recovery of both hard and soft tissues occurs uneventfully, resulting in horizontal and vertical tissue loss, affecting prosthetic rehabilitation with dental implants or tooth-supported prosthesis.
Aim of the study:
The aim of this study is to evaluate volumetric soft tissue alterations as well as clinical, radiographic, and esthetic outcomes in dual zone technique (DZ) using CTG (Connective Tissue Graft) versus CGF (Concentrated Growth Factor) Graft following maxillary IIP (Immediate Implant Placement) in the esthetic zone.
Materials and methods:
20 patients with hopeless teeth requiring extraction in maxillary esthetic zone and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain Shams University according to the inclusion criteria. They will be randomly allocated into two equal groups. Group I (n=17) immediate implant placement with dual zone technique using concentrated growth factor graft and group II (n=17) immediate implant placement with dual zone technique using connective tissue graft. Pink esthetic score (PES) was measured 6 months after the final crown placement. At the respective times radiographic CBCT measurements, volumetric analysis, and clinical measurements will be taken. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.
Detailed description
Maintaining the natural esthetic appearance, particularly in the esthetic zone, together with the volume and contour of the soft tissue in harmony with the surrounding teeth soft tissue, is believed to be critical. However, postponing implant placement until hard and soft tissues have fully healed usually necessitates additional surgical intervention steps, such as guided bone regeneration or ridge splitting, or implant placement in undesirable positions with a low esthetic appearance to overcome alveolar ridge resorption.
In clinical practice, immediate implant placement (IIP) in the esthetic zone has been regarded as an ongoing concern. Immediate implant placement (IIP) aims to minimize the duration of therapy overall, cost-effectiveness, and patient aesthetic expectations. However, the physician needs to be aware of potential risks and undesirable effects associated with this surgery, such as early implant loss and dimensional alterations in soft and hard tissues. Clinical research continues to advance to improve predictability and minimize the occurrence of undesirable consequences following IIP due to evolving patients\' esthetic demands and expectations.
Over the years, numerous surgical techniques have been proposed to preserve the soft and hard tissues in the esthetic zone. These techniques include proper 3D implant positioning, flapless approach, the addition of bone graft, the use of grafts containing growth factors such as concentrated growth factor (CGF) and platelet-rich fibrin (PRF) membranes, the application of connective tissue grafts (CTG), the socket shield technique, or the use of customized healing abutments. In order to offset the peri-implant tissue reduction, various treatments were also devised, including vestibular socket therapy, the dual-zone concept (DZ), and immediate dentoalveolar restoration.
From the above-mentioned approaches, Dual Zone technique was utilized in conjunction with CTG, and CGF graft were primarily advised for peri-implant soft tissue phenotypic preservation, stability, and health. The dual-zone (DZ) concept was developed to reduce the amount of buccal contour change at the extraction site while enhancing the thickness of the peri- implant soft tissues by filling the buccal gap with bone graft in two zones: the bone zone up to the crest of the socket bone and the soft tissue zone. To illustrate, graft particles are absorbed into tissues, increasing their thickness while also providing stability and maintaining soft tissue volume. As a result, the DZ concept aims to maintain the gingival contour while providing excellent soft tissue esthetics.
Connective tissue graft (CTG) and concentrated growth factor (CGF) graft are two commonly used materials for soft tissue augmentation in implant dentistry. CTG has a long history of success in improving soft tissue volume and quality around dental implants by forming a scaffold for cell migration and tissue regeneration. On the other hand, CGF, a newer autologous platelet concentrate rich in growth factors, has demonstrated promising results in stimulating tissue healing and regeneration, potentially outperforming standard graft materials.
To begin with, the success of utilizing CTG in covering exposed roots and increasing the width of the keratinized mucosa (WKM) prompted research into its usage in conjunction with immediate dental implants to improve their final esthetic effects. CTG is thought to be the gold standard for dimensional stability together with IIP in the esthetic zone. Furthermore, inserting CTG concurrently with IIP was claimed to reduce the likelihood of advanced mid-facial mucosal recession, prevent papillae loss, improve soft tissue contour, and reduce crestal bone resorption independent of tissue biotype. Other researches, however, argued that using CTG resulted in bone resorption and lost dimensional stability over time.
Platelets naturally produce Growth factors (GF) such as platelet-derived GF, Transforming GF (TGF)-β1 and β2 (TGF-β2), fibroblast GF, vascular endothelial GF, and insulin-like GF, which promote cell proliferation, matrix remodeling, and angiogenesis. Concentrated GF (CGF) is prepared by centrifuging venous blood, which concentrates platelets in a gel layer made up of a fibrin matrix rich in GFs and leukocytes. CGF operates by degranulating alpha granules in platelets, which play an important role in early wound healing. CGF has been shown to contain more GFs than other platelet-based preparations such as platelet rich fibrin (PRF) and platelet-rich plasma (PRP), and unlike PRP, CGF does not dissolve quickly after application. Furthermore, it was demonstrated that CGF may release GFs for at least 13 days.
CGF, first introduced by Sacco, has recently gained popularity. It is produced by centrifugation of venous blood, similar to PRF, but at a different speed (2400-2700 rpm) to separate cells in the venous blood, resulting in fibrin rich blocks that are much larger, denser, and richer in GF than common PRF. This demonstrates improved regeneration capacity and versatility when utilizing the fibrin-rich block. Furthermore, many studies showed that CGF has higher tensile strength, more growth factors, higher viscosity, and adhesive strength than PRF. As a result, surgeons can utilize CGF as a barrier membrane to speed up soft tissue healing or mix it with bone graft to expedite new bone growth.
Despite the growing interest in immediate dental implants and soft tissue augmentation techniques, limited comparative evidence exists regarding the efficacy of different grafting materials in the dual zone approach, particularly in the esthetic zone. Therefore, there is a need for well-designed randomized controlled clinical trials to evaluate the comparative effectiveness of CTG and CGF grafts in immediate dental implants using the dual zone technique.
This randomized clinical trial aims to address this gap in the literature by comparing the clinical and radiographic outcomes of immediate dental implants with dual zone technique using CTG versus CGF graft in the esthetic zone. By assessing parameters such as volumetric soft tissue alterations, pink esthetic score, clinical measurements, and radiographic bone dimensional changes, this study aims to provide evidence-based guidance for clinicians in selecting the most appropriate grafting material for achieving optimal esthetic outcomes in implant dentistry.
III. Research Question:
Are soft and hard tissue changes following immediate implant placement with dual zone concept and concentrated growth factor graft the same as dual zone concept and connective tissue graft on volumetric analysis, pink esthetic score, clinical, and radiographic measures at baseline, 6 months, and 1 year?
PICOTS Elements:
Patient/Problem :Patients with hopeless teeth requiring extraction in maxillary esthetic zone.
Intervention : Guided immediate implant placement with dual zone technique using concentrated growth factor graft Comparator : Guided immediate implant placement with dual zone technique using connective tissue graft Outcome: Volumetric analysis, Pink Esthetic Score (PES), clinical assessment and radiographic assessment. Time: Baseline and 6 months. Setting : Faculty of Dentistry, Ain Shams University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel design, two arms clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group I (Test group): | Experimental | Procedure: Immediate implant with with dual zone technique using concentrated growth factor graft.17 patients with non-restorable tooth in the esthetic zone will receive atraumatic extraction followed by immediate implant placement with dual zone technique using concentrated growth factor graft. |
| Group II (Control group): | Active comparator | Procedure: Immediate implant with dual zone technique using connective tissue graft.17 patients with non-restorable tooth in the esthetic zone will receive atraumatic extraction followed by immediate implant placement with dual zone technique using connective tissue graft. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically (medically) free individuals were recruited for the present study according to the modified Burkett's health history questionnaire, ASA.
- Males and females with age range 20 - 50.
- Patients having a history of hopeless tooth in esthetic zone (Anteriors/Premolars) indicated for extraction and immediate implant placement.
- Patients who are cooperative and maintain proper oral hygiene.
- Intact interproximal and palatal bone extending at least 6 mm apically, with sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque).
Key exclusion criteria (3 listed)
- Heavy smokers. 20
- Patients who exhibit parafunctional occlusal habits 21
- Pregnant ladies or lactating mothers.
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 implant with with dual zone technique using concentrated growth factor graft.In the test group, pouch technique + CGFG will be used. The CGFG will be packed in the split-thickness labial pouch between the labial bone plate and the overlying gingiva of the extraction socket. A convenient blood sample will be withdrawn from a peripheral venous blood from the patient using a specialized vacutaine. A standard, disposable, 10-ml non- anticoagulant tube and a matching centrifuge device was used. To prepare the CGFG, the centrifuge is accelerated for 30 seconds, then centrifuged at 2700 rpm for 2 minutes, 2400 rpm for 4 minutes, 2700 rpm for 4 minutes, and 3000 rpm for 3 minutes before being decelerated for 36 seconds to stop. | Procedure or surgery | Group I (Test group): |
| Immediate implant with dual zone technique using connective tissue graft.Patients assigned to the control group will receive pouch technique + CTG. Following implant placement, a split-thickness labial pouch between the labial bone plate and the overlying gingiva of the extraction socket will be performed using 15c mini blade to allow for the placement of a CTG. The pouch preparation will be extended apical beyond the muco-gingival junction and to the neighboring teeth mesiodistally. The CTG will be harvested from the palate with a thickness of 1.5 mm using single-incision technique, which was done approximately 2-3 mm apical to the gingival margin of the maxillary teeth and parallel to the palatal long axis. A resorbable suture will be used to first pierce the labial mucosa along with the periosteum at an apical part, which then exits from the sulcus. Afterward, the CTG will be tucked in the pouch, labial to the suture, and held at a coronal area by using the needle to pierce it from its inner surface toward the labial soft tissue. The knot will then be se | Procedure or surgery | Group II (Control group): |
Primary outcome
Volumetric analysis
Time frame: Baseline and 6 months
3D viewer soft tissue; mm changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin
5 secondary outcomes
Pink Esthetic Score
Time frame: 6 months after final crown placement
Radiographic CBCT measurements
Time frame: Baseline and 6 months
Full-mouth plaque score
Time frame: Baseline and 6 months
Full-mouth bleeding score
Time frame: Baseline and 6 months
Visual Analog Scale
Time frame: 1, 3, and 7 days after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Related trials for Hopeless Tooth in Esthetic Zone
Enrolling by invitation
Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction
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 Immediate implant with with dual zone technique using concentrated growth factor graft. and Immediate implant with dual zone technique using connective tissue graft. in people with Hopeless Tooth in Esthetic Zone and Loss of Soft and Hard Tissue Around Implant, run by Ain Shams 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 3 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 17 Feb 2025. 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?
Results are not available in the source record.
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?
Volumetric analysis (time frame: Baseline and 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 17 Feb 2025.