Implant ComplicationNCT06313216
Treatment of Peri-implant Bone Dehiscence Using Autogenous Tooth Plate
A study testing duoteck membrane, autogenous demineralized tooth graft and autogenous demineralized tooth graft and plate in people with Implant Complication and Peri-Implantitis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication, Peri-Implantitis, Periodontal Diseases
- What is being tested?
- duoteck membrane, autogenous demineralized tooth graft and autogenous demineralized tooth graft and plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 15 Nov 2025
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- above the age of 18years
- presence of non-restorable maxillary anterior tooth
- had intact socket walls following tooth extraction
- the gingival biotype was thick.
Who cannot join
- history of systemic condition
- history of using bisphosphonates or other drugs that might impact bone turnover
- a history of smoking during the previous five years,
- a history of any acute infections at the surgical site,
- teeth having root resorptions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Efficacy of Autogenous Tooth Plates for the Treatment of Peri-implant Bone Dehiscence Following Immediate Implantation in Maxillary Esthetic Zone: Randomized Clinical Trial
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.
The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate.
Read the detailed description
Patients with missing teeth face the prospect of tooth replacement either through the use of removable prostheses, fixed natural teeth-supported prostheses, or implant-supported prostheses. In many circumstances, implants are the alternative to fixed or removable prosthetic appliances.
One of the various indications of implant therapy is the replacement of periodontally hopeless teeth. The successful use of dental implants for more than 3 decades has been extensively documented for both conventional and immediate implant therapy.
The installation of implants in extraction sockets was advocated as a means to reduce the number of surgical procedures; to preserve the dimensions of the alveolar ridge; to reduce the interval between the removal of the tooth and the insertion of the implant supported restoration and furthermore, it may enhance osseointegration by taking advantage of the natural bone healing process around the implant.
A variety of regenerative techniques using combinations of bone grafts and barrier membranes have been suggested to promote bone regeneration in localized defects at implants placed into extraction sockets (Mayfield 1999). Bone substitutes were used to fill the marginal void between the implant and the bone, and barrier membranes were placed to protect the site during healing.
In the presence of fenestration or dehiscence defects, the potential for spontaneous bone formation at such defects is poor, so it is advised to use augmentation procedures for bone enhancement. Bone augmentation procedures are effective in promoting bone fill and defect resolution at implants placed in post-extraction sites, and are more successful with immediate and immediate-delayed placement than with conventional delayed placement.
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.
- Conditions
- Implant Complication, Peri-Implantitis, Periodontal Diseases
- Being tested
- duoteck membrane, autogenous demineralized tooth graft, autogenous demineralized tooth graft and plate
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duoteck membraneProcedure or surgery
the dehisced bone defect will be covered with duoteck membrane
autogenous demineralized tooth graftProcedure or surgery
the dehisced bone defect will be covered with autogenous demineralized tooth graft
autogenous demineralized tooth graft and plateProcedure or surgery
the dehisced bone defect will be covered with autogenous demineralized tooth graft combined with autogenous demineralized tooth plate
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant Placement Using duoteck membrane | Experimental | after insertion of immediate implant, the dehisced bone defect will be grafted Using duoteck membrane Receives: Procedure: duoteck membrane |
| Immediate Implant Placement autogenous demineralized tooth graft | Experimental | after insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft Receives: Procedure: autogenous demineralized tooth graft |
| Immediate Implant Placement with autogenous demineralized tooth graft and tooth plate | Experimental | after insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft and autogenous demineralized tooth plate Receives: Procedure: autogenous demineralized tooth graft and plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Quotient of dental implant (SQDI)
Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Measured: 12-month.
pink esthetic score (PES)
The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Measured: 12-month.
facial marginal bone level (FMBL)
Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
Measured: 12-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024
- Primary completion30 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with duoteck membrane, while group II was grafted by autogenous demineralized tooth graft, but group III was grafted with autogenous demineralized tooth graft with autogenous demineralized tooth plate Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- Walid AH Elamrousy, PhD, Principal investigator, Faculty of Oral and Dental Medicine, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313216
- Sponsor's protocol ID
- KFSIRB200-187
- Status last verified
- Nov 2025
- First submitted
- 9 Mar 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Autogenous Tooth Plates for the Treatment of Peri-implant Bone Dehiscence Following Immediate Implantation in Maxillary Esthetic Zone: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06313216
- Acronym / sponsor ID
- KFSIRB200-187
- Conditions
- Implant Complication, Peri-Implantitis, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 15 Mar 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.
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.
The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate.
Detailed description
Patients with missing teeth face the prospect of tooth replacement either through the use of removable prostheses, fixed natural teeth-supported prostheses, or implant-supported prostheses. In many circumstances, implants are the alternative to fixed or removable prosthetic appliances.
One of the various indications of implant therapy is the replacement of periodontally hopeless teeth. The successful use of dental implants for more than 3 decades has been extensively documented for both conventional and immediate implant therapy.
The installation of implants in extraction sockets was advocated as a means to reduce the number of surgical procedures; to preserve the dimensions of the alveolar ridge; to reduce the interval between the removal of the tooth and the insertion of the implant supported restoration and furthermore, it may enhance osseointegration by taking advantage of the natural bone healing process around the implant.
A variety of regenerative techniques using combinations of bone grafts and barrier membranes have been suggested to promote bone regeneration in localized defects at implants placed into extraction sockets (Mayfield 1999). Bone substitutes were used to fill the marginal void between the implant and the bone, and barrier membranes were placed to protect the site during healing.
In the presence of fenestration or dehiscence defects, the potential for spontaneous bone formation at such defects is poor, so it is advised to use augmentation procedures for bone enhancement. Bone augmentation procedures are effective in promoting bone fill and defect resolution at implants placed in post-extraction sites, and are more successful with immediate and immediate-delayed placement than with conventional delayed placement.
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with duoteck membrane, while group II was grafted by autogenous demineralized tooth graft, but group III was grafted with autogenous demineralized tooth graft with autogenous demineralized tooth plate Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Placement Using duoteck membrane | Experimental | Procedure: duoteck membraneafter insertion of immediate implant, the dehisced bone defect will be grafted Using duoteck membrane |
| Immediate Implant Placement autogenous demineralized tooth graft | Experimental | Procedure: autogenous demineralized tooth graftafter insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft |
| Immediate Implant Placement with autogenous demineralized tooth graft and tooth plate | Experimental | Procedure: autogenous demineralized tooth graft and plateafter insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft and autogenous demineralized tooth plate |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- above the age of 18years
- presence of non-restorable maxillary anterior tooth
- had intact socket walls following tooth extraction
- the gingival biotype was thick.
Key exclusion criteria (5 listed)
- history of systemic condition
- history of using bisphosphonates or other drugs that might impact bone turnover
- a history of smoking during the previous five years,
- a history of any acute infections at the surgical site,
- teeth having root resorptions
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 |
|---|---|---|
| duoteck membranethe dehisced bone defect will be covered with duoteck membrane | Procedure or surgery | Immediate Implant Placement Using duoteck membrane |
| autogenous demineralized tooth graftthe dehisced bone defect will be covered with autogenous demineralized tooth graft | Procedure or surgery | Immediate Implant Placement autogenous demineralized tooth graft |
| autogenous demineralized tooth graft and platethe dehisced bone defect will be covered with autogenous demineralized tooth graft combined with autogenous demineralized tooth plate | Procedure or surgery | Immediate Implant Placement with autogenous demineralized tooth graft and tooth plate |
Primary outcome
Stability Quotient of dental implant (SQDI)
Time frame: 12-month.
Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
pink esthetic score (PES)
Time frame: 12-month.
The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
facial marginal bone level (FMBL)
Time frame: 12-month.
Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
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 21 Nov 2025.
- Individual participant dataSharing planned: Undecided. 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. This study is not recruiting at the moment.
Walid AH Elamrousy, PhD principal investigator
Faculty of Oral and Dental Medicine, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duoteck membrane, autogenous demineralized tooth graft and autogenous demineralized tooth graft and plate in people with Implant Complication and Peri-Implantitis, run by Kafrelsheikh 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 4 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: finished, as of the sponsor's last update on 21 Nov 2025. 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?
Stability Quotient of dental implant (SQDI) (time frame: 12-month.). The study lists 3 primary outcomes in all. 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 21 Nov 2025.