Papilla Reconstructiondelay implantNCT04843826
Modified Pedicle Subepithelial Connective Tissue Graft for Interdental Papillary Reconstruction Around Delayed Implants in the Esthetic Zone: A Case Series Trail
A study testing papilla reconstruction in people with Papilla Reconstruction, run by Ahmed Sadek Mohamed at 1 site in Egypt.
Trial summary
This case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Papilla Reconstruction
- What is being tested?
- papilla reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2020to 14 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, et al., 2009)
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Presence of systemic disease that would affect wound healing
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Faculty of Dentistry
Cairo, Manial, 11865
Ahmed Sadek mohamed, master, 23634965 ext. 3, ahmed.sadek@dentistry.edu.cu.eg
About this study
Official title: تعديل النسيج الضام عنيق تحت الظهارة من أجل إعادة بناء حليمي بين الأسنان حول الزراعه المتأخره في المنطقة الجمالية
This case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics.
Read the detailed description
- Preparation of the implant site will be prepared by a crestal incision on the ridge bisecting the existing keratinized mucosa and vertical releasing incisions extending to the vestibule. The papillae of the adjacent teeth are not included in the flap design.
- A full thickness flap will be raised buccally exposing the underlined ridge of the implant site. A surgical drill guide will be used for the precise placement of the pilot drill. After pilot drill application, the osteotomy will be prepared with the corresponding size of parallel drill.
- The implant will be placed in the recipient site by means of an insertion device. The implant neck will be positioned flushing with the crestal bone level.
- The healing abutment extension of the implant will be placed in such a way that the head of the implant protruded about 2 to 3 mm from the bone crest.
- Reassessment of the case to assure absence of any signs of inflammation and presence of normal tissues before the surgical procedure
- Conditions
- Papilla Reconstruction
- Being tested
- papilla reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
papilla reconstructionProcedure or surgery
Also called create papilla around delayed implant
subepithelial connective tissue graft for interdental papillary reconstruction around delayed
| Study group | Role | What they receive |
|---|---|---|
| delayed implant | Experimental | 1. Patients 18 years or older.
2. Periodontally and systemically healthy.
3. Sufficient bone width and height for implant placement
4. Adequate mesiodistal width and inter-arch space for placement of a delayed implant.
5. Full mouth plaque index less than 15% (Bentley and Disney, 1995)
6. cooperative patients who will comply to follow up visits Receives: Procedure: papilla reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
papilla height
Periodontal probe and reference line
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start14 Apr 2020
- Primary completion20 May 2020
- Study completion14 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilla ReconstructionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Case Series trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Sadek Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Sadek Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843826
- Sponsor's protocol ID
- PER 111
- Other IDs
- per 122
- Acronym
- delay implant
- Status last verified
- Apr 2020
- First submitted
- 4 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- تعديل النسيج الضام عنيق تحت الظهارة من أجل إعادة بناء حليمي بين الأسنان حول الزراعه المتأخره في المنطقة الجمالية
- ClinicalTrials.gov ID
- NCT04843826
- Acronym / sponsor ID
- delay implant / PER 111
- Conditions
- Papilla Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ahmed Sadek MohamedUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 14 Sep 2021 (estimated)
- First posted
- 14 Apr 2021 (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 case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics.
Detailed description
- Preparation of the implant site will be prepared by a crestal incision on the ridge bisecting the existing keratinized mucosa and vertical releasing incisions extending to the vestibule. The papillae of the adjacent teeth are not included in the flap design.
- A full thickness flap will be raised buccally exposing the underlined ridge of the implant site. A surgical drill guide will be used for the precise placement of the pilot drill. After pilot drill application, the osteotomy will be prepared with the corresponding size of parallel drill.
- The implant will be placed in the recipient site by means of an insertion device. The implant neck will be positioned flushing with the crestal bone level.
- The healing abutment extension of the implant will be placed in such a way that the head of the implant protruded about 2 to 3 mm from the bone crest.
- Reassessment of the case to assure absence of any signs of inflammation and presence of normal tissues before the surgical procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series trial
| Arm | Type | Receives |
|---|---|---|
| delayed implant | Experimental | Procedure: papilla reconstruction1. Patients 18 years or older. 2. Periodontally and systemically healthy. 3. Sufficient bone width and height for implant placement 4. Adequate mesiodistal width and inter-arch space for placement of a delayed implant. 5. Full mouth plaque index less than 15% (Bentley and Disney, 1995) 6. cooperative patients who will comply to follow up visits |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, et al., 2009)
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Presence of systemic disease that would affect wound healing
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 |
|---|---|---|
| papilla reconstructionAlso: create papilla around delayed implantsubepithelial connective tissue graft for interdental papillary reconstruction around delayed | Procedure or surgery | delayed implant |
Primary outcome
papilla height
Time frame: 3 month
Periodontal probe and reference line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing papilla reconstruction in people with Papilla Reconstruction, run by Ahmed Sadek Mohamed 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 0 inclusion and 5 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 14 Apr 2021. 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?
Contact Ahmed Sadek Mohamed, master (23634965 ext. 3, ahmed.sadek@dentistry.edu.cu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
papilla height (time frame: 3 month). 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 14 Apr 2021.