Dental ImplantNCT07333534
Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants
A study testing Immediate dental implant in the esthetic zone in people with Dental Implant, run by University of Baghdad at 1 site in Iraq.
Trial summary
This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Immediate dental implant in the esthetic zone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIraq
- Study dates
- 20 Dec 2025to 1 Jul 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone.
- The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth.
- Sufficient bone (>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm).
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
Who cannot join
- Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- Teeth with current acute periapical infection.
- Dehiscence of the labial (facial) bone plate after extraction.
- Signs of uncontrolled periodontal disease.
- Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals).
- History of head and neck radiation therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khalid Khalid, Bachelor of Dental Surgery contact
Iraq1 site, 1 recruiting
- Recruiting
University of Baghdad/ College of Dentistry/ Department of Oral and Maxillofacial surgery/ Implant Unit
Baghdad, Rusafa, 10047
Hassanien Al-Jumaily, +9647708896181, hassanienaljumaily@codental.uobaghdad.edu.iq
About this study
Official title: Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study
This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation.
Subjects will randomly assigned to one of two groups:
Read more
- Group A (control group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation only.
- Group B (study group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation and connective tissue graft (CTG).
The main questions it aims to answer is:
Is there is a significant difference in the esthetic outcome between bone augmentation alone and bone augmentation combined with connective tissue graft after immediate dental implant in the esthetic zone?
- Conditions
- Dental Implant
- Being tested
- Immediate dental implant in the esthetic zone
- Keywords
- immediate implant, maxillary esthetic zone, CTG, jumping gap, bone augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implant in the esthetic zoneProcedure or surgery
Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.
| Study group | Role | What they receive |
|---|---|---|
| Hard tissue augmentation with connective tissue graft | Experimental | Hard tissue augmentation (bone grafting) with additional connective tissue graft (CTG) performed at the same time following immediate dental implant in the esthetic zone Receives: Procedure: Immediate dental implant in the esthetic zone |
| Hard tissue augmentation | Active comparator | Hard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone. Receives: Procedure: Immediate dental implant in the esthetic zone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score (PES)
Seven variables to be scored: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process, soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter to obtain a final score of 14.
Measured: Pink esthetic score (PES) will be assessed at 6 months postoperatively.
Secondary outcomes (4)
Hard tissue assessment (facial bone thickness)
Using Cone-Beam Computed Tomography (CBCT) to assess the thickness of the facial (labial/buccal) plate of bone at two points: the implant platform and a point 5mm apical to the implant platform.
Measured: 6 months postoperatively
Patient satisfaction questionnaire
Assessment of patient satisfaction will be performed at 6 months postoperatively with a self-administered patient questionnaire regarding overall satisfaction and satisfaction of color and shape of the mucosa using a visual analogue scale (VAS, left = very dissatisfied [0], right = very satisfied [10].
Measured: 6 months postoperatively
Implant survival rate
Implant survival rate at 6 months (defined by absence of mobility, infection, pain, and peri-implant bone loss).
Measured: 6 months postoperatively
Rate of complications
complications such as infection, graft rejection and peri-implantitis will be assessed from the intervention up to 6 months postoperatively.
Measured: From the intervention to 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Walid Khalid, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333534
- Sponsor's protocol ID
- 973124
- Status last verified
- Nov 2025
- First submitted
- 15 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07333534
- Acronym / sponsor ID
- 973124
- Conditions
- Dental Implant
- Keywords
- immediate implant, maxillary esthetic zone, CTG, jumping gap, bone augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation.
Subjects will randomly assigned to one of two groups:
- Group A (control group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation only.
- Group B (study group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation and connective tissue graft (CTG).
The main questions it aims to answer is:
Is there is a significant difference in the esthetic outcome between bone augmentation alone and bone augmentation combined with connective tissue graft after immediate dental implant in the esthetic zone?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hard tissue augmentation with connective tissue graft | Experimental | Procedure: Immediate dental implant in the esthetic zoneHard tissue augmentation (bone grafting) with additional connective tissue graft (CTG) performed at the same time following immediate dental implant in the esthetic zone |
| Hard tissue augmentation | Active comparator | Procedure: Immediate dental implant in the esthetic zoneHard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone.
- The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth.
- Sufficient bone (>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm).
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
Key exclusion criteria (6 listed)
- Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- Teeth with current acute periapical infection.
- Dehiscence of the labial (facial) bone plate after extraction.
- Signs of uncontrolled periodontal disease.
- Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals).
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 dental implant in the esthetic zonePlacement of immediate dental implant after tooth extraction in the maxillary esthetic zone. | Procedure or surgery | Hard tissue augmentation, Hard tissue augmentation with connective tissue graft |
Primary outcome
Pink Esthetic Score (PES)
Time frame: Pink esthetic score (PES) will be assessed at 6 months postoperatively.
Seven variables to be scored: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process, soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter to obtain a final score of 14.
4 secondary outcomes
Hard tissue assessment (facial bone thickness)
Time frame: 6 months postoperatively
Patient satisfaction questionnaire
Time frame: 6 months postoperatively
Implant survival rate
Time frame: 6 months postoperatively
Rate of complications
Time frame: From the intervention to 6 month postoperatively
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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Khalid Khalid, Bachelor of Dental Surgery contact
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 dental implant in the esthetic zone in people with Dental Implant, run by University of Baghdad at 1 site in Iraq.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. 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 Iraq. 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?
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 Khalid Khalid, Bachelor of Dental Surgery (+9647716641706, khaled.waleed2408m@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (PES) (time frame: Pink esthetic score (PES) will be assessed at 6 months postoperatively.). 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 13 Mar 2026.