Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant PlacementNCT05975515
Midfacial Gingival Margin Changes Following Immediate Implants.
A study testing Connective tissue graft /Bone graft/ Customized HA in people with Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement, run by Cairo University at 1 site in Egypt.
Trial summary
Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement
- What is being tested?
- Connective tissue graft /Bone graft/ Customized HA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2022to 30 May 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- 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.
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- Good oral hygiene.
- 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
1 site in 1 country.
About this study
Official title: Effect of Soft Tissue Volume on Midfacial Gingival Margin Alterations Following Immediate Implant Placement in the Esthetic Zone: A 1-Year Randomized Clinical and Volumetric Trial
Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics
Read the detailed description
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).
- Conditions
- Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement
- Being tested
- Connective tissue graft /Bone graft/ Customized HA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graft /Bone graft/ Customized HAProcedure or surgery
Also called Customized Healing abutment
Soft tissue management and augmentation
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with bone grafts till crest | Active comparator | Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment. Receives: Procedure: Connective tissue graft /Bone graft/ Customized HA |
| immediate implant placement with customized healing abutment | Experimental | Group 2 (intervention 1 group): Immediate implant placement with CTG and customized healing abutment. Receives: Procedure: Connective tissue graft /Bone graft/ Customized HA |
| immediate implant placement with CTG and customized healing abutment. | Experimental | Group 3 (intervention 2 group): immediate implant placement with customized healing abutment Receives: Procedure: Connective tissue graft /Bone graft/ Customized HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midfacial Gingival Margin Changes
will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.
Measured: 12 months
Secondary outcomes (2)
Bone labial to the implant
Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland.
Measured: 12 months
Volumetric analysis of buccal contour&Total Volume
To evaluate tissue volume 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, at 3, 6 and 12 months and will be compared to the presurgical scanned casts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start13 Jan 2022
- Primary completion30 Apr 2023
- Study completion30 May 2023
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 Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant PlacementStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aboulfettouh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975515
- Sponsor's protocol ID
- PER 2612
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fettouh AIA, Ghallab NA, Ghaffar KA, Elarab AE, Abdel-Aziz NG, Mina NA, Shemais NM, Dahab OA. Effect of soft tissue volume on midfacial gingival margin alterations following immediate implant placement in the esthetic zone: a 1-year randomized clinical and volumetric trial. BMC Oral Health. 2024 Oct 19;24(1):1256. doi: 10.1186/s12903-024-04845-y.
PubMed 39427143
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soft Tissue Volume on Midfacial Gingival Margin Alterations Following Immediate Implant Placement in the Esthetic Zone: A 1-Year Randomized Clinical and Volumetric Trial
- ClinicalTrials.gov ID
- NCT05975515
- Acronym / sponsor ID
- PER 2612
- Conditions
- Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 4 Aug 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.
Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics
Detailed description
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement with bone grafts till crest | Active comparator | Procedure: Connective tissue graft /Bone graft/ Customized HAGroup1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment. |
| immediate implant placement with customized healing abutment | Experimental | Procedure: Connective tissue graft /Bone graft/ Customized HAGroup 2 (intervention 1 group): Immediate implant placement with CTG and customized healing abutment. |
| immediate implant placement with CTG and customized healing abutment. | Experimental | Procedure: Connective tissue graft /Bone graft/ Customized HAGroup 3 (intervention 2 group): immediate implant placement with customized healing abutment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patient-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
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 |
|---|---|---|
| Connective tissue graft /Bone graft/ Customized HAAlso: Customized Healing abutmentSoft tissue management and augmentation | Procedure or surgery | immediate implant placement with CTG and customized healing abutment., immediate implant placement with bone grafts till crest, immediate implant placement with customized healing abutment |
Primary outcome
Midfacial Gingival Margin Changes
Time frame: 12 months
will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.
2 secondary outcomes
Bone labial to the implant
Time frame: 12 months
Volumetric analysis of buccal contour&Total Volume
Time frame: 12 months
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 Jul 2024.
- Derived from this study: PubMed 39427143Fettouh AIA, Ghallab NA, Ghaffar KA, Elarab AE, Abdel-Aziz NG, Mina NA, Shemais NM, Dahab OA. Effect of soft tissue volume on midfacial gingival margin alterations following immediate implant placement in the esthetic zone: a 1-year randomized clinical and volumetric trial. BMC Oral Health. 2024 Oct 19;24(1):1256. doi: 10.1186/s12903-024-04845-y.
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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 /Bone graft/ Customized HA in people with Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement, run by Cairo 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 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: finished, as of the sponsor's last update on 18 Jul 2024. 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?
Midfacial Gingival Margin Changes (time frame: 12 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 NCT05975515, 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 18 Jul 2024.