Immediate Implants Connective Tissue GraftNCT06592079
Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone
A study testing Immediate implant and connective tissue graft and Immediate implant with connective tissue graft and bone graft in people with Immediate Implants Connective Tissue Graft, run by Cairo University.
Trial summary
Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implants Connective Tissue Graft
- What is being tested?
- Immediate implant and connective tissue graft and Immediate implant with connective tissue graft and bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient-related criteria:
- Adults at or above the age of 18.
- Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
- The failing tooth will have adjacent and opposing natural teeth.
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- Able to tolerate surgical periodontal procedures.
Show all 14Show fewer
- Full mouth plaque and bleeding scores less than 20%.
- Compliance with the maintenance program.
- Provide informed consent.
- Accepts the one-year follow-up period.
- Teeth related criteria:
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
- Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm
Who cannot join
- Patients diagnosed with periodontal diseases.
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with parafunctional habits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone: A Randomized Clinical Trial
Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.
Read the detailed description
This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.
- Being tested
- Immediate implant and connective tissue graft, Immediate implant with connective tissue graft and bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant and connective tissue graftProcedure or surgery
Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.
Immediate implant with connective tissue graft and bone graftProcedure or surgery
Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant & Connective tissue graft | Experimental | Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. Receives: Procedure: Immediate implant and connective tissue graft |
| Immediate implant with connective tissue graft & bone graft | Active comparator | Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will be used to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. Receives: Procedure: Immediate implant with connective tissue graft and bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric Analysis of Mid-facial recession
3d viewer will be used to the the midfacial recession .
Measured: Preoperative,3months,6months and 12 months
Secondary outcomes (11)
Volumetric analysis of Interdental papillae height
Measured: Preoperative , 3 months, 6 months and 12 months
Bone formed labial to the implant
Measured: Preoperative and 1 year
Horizontal labio-palatal bone collapse
Measured: Preoperative and 1 year
Vertical crestal bone level changes
Measured: Preoperative and 1 year
Gingival biotype
Measured: Preoperative, 6 months and 12 months
Volumetric analysis of buccal contour
Measured: Preoperative,3months,6months and 12 months
Horizontal labio-palatal bone collapse
Measured: (Preoperative and 1 year)
Full mouth bleeding score (FMBS)
(0,1,2,3) 0:normal gingiva, 1: No bleeding , 2:bleeding on probing, 3:tendency to spontaneous bleeding.
Measured: Preoperative, 6months and 12 months
Pain and discomfort
will be assessed using the visual analog scale VAS as recorded by the patient 1, 3 and 7 days after the surgery. The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right). It will be given a numerical value by measuring in millimeters the distance from the left end of the line .
Measured: At 1,3 and 7 days after the surgery
Full mouth plaque score (FMPS)
0 : no plaque scored at gingival margin
1: Plaque scored at gingival margin FMPS: Number of sites scored with plaque/Number of sites evaluated x 100
Measured: Preoperative, 6 months and 12 months
Pink Esthetic Score
PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points.The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Nov 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implants Connective Tissue GraftStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norai Ahmed Mohamed Zayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592079
- Sponsor's protocol ID
- 924
- Status last verified
- Oct 2024
- First submitted
- 4 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06592079
- Acronym / sponsor ID
- 924
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 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.
Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.
Detailed description
This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant & Connective tissue graft | Experimental | Procedure: Immediate implant and connective tissue graftTooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. |
| Immediate implant with connective tissue graft & bone graft | Active comparator | Procedure: Immediate implant with connective tissue graft and bone graftTooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will be used to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient-related criteria:
- Adults at or above the age of 18.
- Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
- The failing tooth will have adjacent and opposing natural teeth.
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
Key exclusion criteria (6 listed)
- Patients diagnosed with periodontal diseases.
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- Patients with active infection related at the site of implant/bone graft 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 |
|---|---|---|
| Immediate implant and connective tissue graftTooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. | Procedure or surgery | Immediate implant & Connective tissue graft |
| Immediate implant with connective tissue graft and bone graftTooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. | Procedure or surgery | Immediate implant with connective tissue graft & bone graft |
Primary outcome
Volumetric Analysis of Mid-facial recession
Time frame: Preoperative,3months,6months and 12 months
3d viewer will be used to the the midfacial recession .
11 secondary outcomes
Volumetric analysis of Interdental papillae height
Time frame: Preoperative , 3 months, 6 months and 12 months
Bone formed labial to the implant
Time frame: Preoperative and 1 year
Horizontal labio-palatal bone collapse
Time frame: Preoperative and 1 year
Vertical crestal bone level changes
Time frame: Preoperative and 1 year
Gingival biotype
Time frame: Preoperative, 6 months and 12 months
Volumetric analysis of buccal contour
Time frame: Preoperative,3months,6months and 12 months
Horizontal labio-palatal bone collapse
Time frame: (Preoperative and 1 year)
Full mouth bleeding score (FMBS)
Time frame: Preoperative, 6months and 12 months
Pain and discomfort
Time frame: At 1,3 and 7 days after the surgery
Full mouth plaque score (FMPS)
Time frame: Preoperative, 6 months and 12 months
Pink Esthetic Score
Time frame: at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes
Related trials for Immediate Implants Connective Tissue Graft
Active, not recruiting
Effect of Subepithelial Connective Tissue Graft With Socket Shield Technique
Socket Shield Technique Implant Placement, Immediate Implant Placement
Not yet recruiting
Immediate Implant Placement With Subepithelial Connective Tissue Grafting and Probiotics
Dental Implant Failed
Recruiting
Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants
Dental Implant
Not yet recruiting
Immediate Implants in Front Teeth With Bone Loss: Regeneration and Temporary Crown in a Randomized Clinical Study
Immediate Dental Implant Placement, Connective Tissue Graft
Recruiting
Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement
Bone Resorption
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.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant and connective tissue graft and Immediate implant with connective tissue graft and bone graft in people with Immediate Implants Connective Tissue Graft, run by Cairo 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 14 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Oct 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norai Ahmed Zayed, Masters Degree (+201221444954, norai.zayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric Analysis of Mid-facial recession (time frame: Preoperative,3months,6months and 12 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 15 Oct 2024.