Immediate Dental Implants Connective Tissue Graft Esthetic ZoneNCT03334994
Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.
A study testing Intervention group:(Group B) connective tissue graft combined with immediate implant. in people with Immediate Dental Implants Connective Tissue Graft Esthetic Zone, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Immediate Dental Implants Connective Tissue Graft Esthetic Zone
- What is being tested?
- Intervention group:(Group B) connective tissue graft combined with immediate implant.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 2 Feb 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-55
- Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area.
- Patients with adequate bone volume for the dental implant procedure.
- Patients who are compliant to oral hygiene measures.
- Patient consent approval and signing.
Who cannot join
- Heavy smokers.
- Systemic disease that contraindicates implant placement or surgical procedures.
- No or poor patient's compliance.
- Psychological problems.
- Pathology at the site of intervention.
- Pregnancy females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in the Esthetic Zone. Randomized Controlled Trial.
Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.
Read the detailed description
P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing.
P.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology Department - Cairo University. Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
- Being tested
- Intervention group:(Group B) connective tissue graft combined with immediate implant.
- Keywords
- Immediate dental implant, Connective tissue graft, Esthetic zone.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group:(Group B) connective tissue graft combined with immediate implant.Procedure or surgery
Patients will be treated with connective tissue graft combined with immediate implant.
| Study group | Role | What they receive |
|---|---|---|
| Control group: immediate implant alone | Active comparator | Patient will be treated with immediate implant alone. Receives: Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant. |
| (Group A) immediate implant alone | Active comparator | Patient will be treated with immediate implant alone. Receives: Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial gingival level
FGL was evaluated by measuring the distance between the level of soft tissues and the lower border of the customized template that was used as a reference line at three readings mesially, mid-facially and distally.
Measured: Up to 6 months
Secondary outcomes (8)
Pain score
Visual analog scale was recorded every day for 12 days follow-up and the patient marks on the line the point they feel that it represents their response
Measured: Up to 12 days
Patient satisfaction
Post-Surgical Patient Satisfaction Questionnaire (PSPSQ). The patient questionnaire evaluates patients' perception and subjective admiration of the final result of the treatment
Measured: Up to 6 month
Tissue biotype
Thickness of the peri-implant mucosa around the implant
Measured: Up to 6 months
Pink esthetic score
seven different variables: mesial papilla, distal papilla, facial soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site
Measured: Up to 6 months
Width of keratinized mucosa
distance from the mucogingival junction (MGJ) to the gingival margin
Measured: Up to 6 months
Bleeding on probing
Bleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe.
Measured: Up to 6 months
Probing depth
distance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus
Measured: Up to 6 months
Probing attachment level
distance from the base of the peri-implant sulcus to the implant shoulder using periodontal probe at four sites
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental Implants Connective Tissue Graft Esthetic ZoneStudies 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
- Model description
- The patients was randomly classified into two groups: Group A: Patient will be treated with immediate implant alone. Group B: Patients will be treated with connective tissue graft combined with immediate implant.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parryhan Mohamed Abdelsamie, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334994
- Sponsor's protocol ID
- 302017
- Status last verified
- Jun 2020
- First submitted
- 2 Nov 2017
- Last updated
- 9 Jun 2020
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in the Esthetic Zone. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03334994
- Acronym / sponsor ID
- 302017
- Keywords
- Immediate dental implant, Connective tissue graft, Esthetic zone.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 7 Nov 2017 (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.
Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.
Detailed description
P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing.
P.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology Department - Cairo University. Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients was randomly classified into two groups: Group A: Patient will be treated with immediate implant alone. Group B: Patients will be treated with connective tissue graft combined with immediate implant.
| Arm | Type | Receives |
|---|---|---|
| Control group: immediate implant alone | Active comparator | Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.Patient will be treated with immediate implant alone. |
| (Group A) immediate implant alone | Active comparator | Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.Patient will be treated with immediate implant alone. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-55
- Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area.
- Patients with adequate bone volume for the dental implant procedure.
- Patients who are compliant to oral hygiene measures.
- Patient consent approval and signing.
Key exclusion criteria (6 listed)
- Heavy smokers.
- Systemic disease that contraindicates implant placement or surgical procedures.
- No or poor patient's compliance.
- Psychological problems.
- Pathology at the site of intervention.
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 |
|---|---|---|
| Intervention group:(Group B) connective tissue graft combined with immediate implant.Patients will be treated with connective tissue graft combined with immediate implant. | Procedure or surgery | (Group A) immediate implant alone, Control group: immediate implant alone |
Primary outcome
Facial gingival level
Time frame: Up to 6 months
FGL was evaluated by measuring the distance between the level of soft tissues and the lower border of the customized template that was used as a reference line at three readings mesially, mid-facially and distally.
8 secondary outcomes
Pain score
Time frame: Up to 12 days
Patient satisfaction
Time frame: Up to 6 month
Tissue biotype
Time frame: Up to 6 months
Pink esthetic score
Time frame: Up to 6 months
Width of keratinized mucosa
Time frame: Up to 6 months
Bleeding on probing
Time frame: Up to 6 months
Probing depth
Time frame: Up to 6 months
Probing attachment level
Time frame: Up to 6 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 9 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Immediate Dental Implants Connective Tissue Graft Esthetic Zone
Recruiting
Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants
Dental Implant
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 Intervention group:(Group B) connective tissue graft combined with immediate implant. in people with Immediate Dental Implants Connective Tissue Graft Esthetic Zone, 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 5 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 9 Jun 2020. 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?
Facial gingival level (time frame: Up to 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 9 Jun 2020.