Intrabony Periodontal DefectNCT06041854
Allograft With Enamel Matrix Derivative Versus Allograft Alone in the Treatment of Intrabony Defects .
A study testing Freeze-dried bone allograft combined with Enamel Matrix derivative and Freeze-dried bone allograft in people with Intrabony Periodontal Defect, run by Mansoura University at 1 site in Egypt.
Trial summary
Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Freeze-dried bone allograft combined with Enamel Matrix derivative and Freeze-dried bone allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2022to 22 Feb 2024
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 30-50 years.
- Patients with stage III periodontitis, will be diagnosed on the basis of probing pocket depth and clinical attachment loss.
- Presence of at least one or more radiographically detectable intrabony defect with clinical periodontal pocket depth (PPD) ≥5 mm, clinical attachment loss ≥5 mm, and radiographic depth of the intrabony defect ≥3 mm.
- No periodontal therapy within the last 6 months
Who cannot join
- Smoker and alcoholic patient.
- Patient with any signs, symptoms or history of systemic disease that might affect the periodontium and interfere with healing process.
- Pregnant patients.
- Patient who has traumatic occlusion.
- Uncooperative patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Allograft and Enamel Matrix Derivative and Allograft in Treatment of Intrabony Defects
Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss.
All patients will receive full mouth scaling and root planing and be re-evaluated to assess patient cooperation and maintaining good oral hygiene. Subjects who showed persistent PPD ≥ 5 mm with radiographic evidence of periodontal intrabony defect presence will be included and will be randomly allocated to one of two treatment groups.One group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative. second group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft .Clinical periodontal parameters (PI, GBI, PPD, CAL) will be re-evaluated at 3, 6 and 9 months after surgery. CBCT will be taken after 9 months of surgery and the defect measurements will be recorded
Read the detailed description
primary goal of periodontal therapy is not arrest the tissue destruction caused periodontal disease only, but also to reconstruct the tissue lost caused by infectious process. Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss. Surgical intervention is considered the treatment of choice for deep intrabony defects, which have not resolved following completion of cause-related periodontal therapy.
In general, periodontal studies showed that healing of periodontal defect after conventional periodontal therapy by collagenous tissue with epithelial cell migration within the gingival connective tissue and along the root surface. Therefore, a various of methods and techniques used to prevent epithelial ingrowth to the defect site and permit only a selective periodontal cells proliferation in attempt to regenerate periodontal tissues. Regenerative procedures including the use of certain types of bone replacement materials, barrier membranes, enamel matrix derivative (EMD), or various combinations thereof have been shown to facilitate periodontal regeneration characterized histologically by formation of root cementum, periodontal ligament, and alveolar bone and result superior in clinical, and radiographical patient reported outcomes compared to access flap surgery alone.
Various bone graft and bone substitutes materials can be helpful in the tissue restoration. This bone graft include autogenous bone graft, allografts, xenografts, and alloplastic materials. Autologous bone is considered the gold standard because of its biological activity due to vital cells and growth factors. Yet, the autologous bone from intra-oral donor sites is of restricted quantities and availability, and the bone tissue obtained from the iliac crest is described to show faster resorption. Moreover, the harvesting of autologous bone often requires a second surgical site associated with an additional bone defect, potential donor site morbidity limiting their application.
In recent years, the use of allogeneic human bone has been favored worldwide, and several histological and morphological studies have demonstrated that, there is no difference in the final stage of incorporation and new bone formation between allografts and autografts. Thus, the application of processed allogenic bone tissue is a reliable and predictable alternative.
Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.
Maxgraft® is allograft bone substitute processed by the Cells+Tissuebank Austria with a special cleaning process (Allotec® process). The purification process keeps the structural features and the interconnected macroporosity of human bone. It preserve natural bone structure and collagen content, therefore it serves as a scaffold for natural bone regeneration and has the potential of complete remodeling into patients' own bone. It is available as purely cancellous as well as cortico-cancellous granules and blocks.
Recently, better outcomes have been reported with a combination of xenograft and enamel matrix derivative (EMD) as it combines the osteoconductive and space-making properties of bone grafts with the ability of bioactive materials to stimulate periodontal regeneration. The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex.
To the best of our knowledge, no previous studies have been performed for assessment of the efficacy of using emdogain with maxgraft.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Freeze-dried bone allograft combined with Enamel Matrix derivative, Freeze-dried bone allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried bone allograft combined with Enamel Matrix derivativeProcedure or surgery
The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft mixed with enamel matrix derivative.
Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle.The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex.
Freeze-dried bone allograftProcedure or surgery
The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft .
Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.
| Study group | Role | What they receive |
|---|---|---|
| freeze-dried bone allograft combined with enamel matrix derivative | Experimental | The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative. Receives: Procedure: Freeze-dried bone allograft combined with Enamel Matrix derivative |
| freeze-dried bone allograft | Active comparator | The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft. Receives: Procedure: Freeze-dried bone allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone defect fill
Cone Beam Computed Tomography (CBCT) will be taken prior to periodontal surgery and after 9 months.
The amount of reduction in the IBD measurements (defect resolution)
Measured: at baseline and 9 months
Secondary outcomes (4)
Clinical attachment level
CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth
Measured: CAL will be measured at base line, 3, 6, 9 months postoperative
Probing pocket depth
PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.
Measured: PD will be measured at base line, 3, 6, 9 months postoperative
Plaque Index
Plaque index will be taken as an indicator for the patient oral hygiene.
Measured: PI will be measured at base line, 3, 6, 9 months postoperative
Gingival Bleeding Index
GBI will be measured according to Ainamo \& Bay (1975)
Measured: GBI will be measured at base line, 3, 6, 9 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start22 Nov 2022
- Primary completion22 Nov 2023
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Test group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograft
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rouida nouri, Mansoura University
- Investigators
- Jilan Youssef, Professor, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041854
- Sponsor's protocol ID
- A02040122
- Status last verified
- Mar 2023
- First submitted
- 11 Sep 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.
PubMed 28805207Garrett S. Periodontal regeneration around natural teeth. Ann Periodontol. 1996 Nov;1(1):621-66. doi: 10.1902/annals.1996.1.1.621.
PubMed 9118274Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.
PubMed 2066446Reynolds MA, Kao RT, Camargo PM, Caton JG, Clem DS, Fiorellini JP, Geisinger ML, Mills MP, Nares S, Nevins ML. Periodontal regeneration - intrabony defects: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S105-7. doi: 10.1902/jop.2015.140378. Epub 2014 Oct 15.
PubMed 25315019Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.
PubMed 25867990Sculean A, Nikolidakis D, Nikou G, Ivanovic A, Chapple IL, Stavropoulos A. Biomaterials for promoting periodontal regeneration in human intrabony defects: a systematic review. Periodontol 2000. 2015 Jun;68(1):182-216. doi: 10.1111/prd.12086.
PubMed 25867987Nibali L, Koidou VP, Nieri M, Barbato L, Pagliaro U, Cairo F. Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:320-351. doi: 10.1111/jcpe.13237.
PubMed 31860134Mertens C, Decker C, Seeberger R, Hoffmann J, Sander A, Freier K. Early bone resorption after vertical bone augmentation--a comparison of calvarial and iliac grafts. Clin Oral Implants Res. 2013 Jul;24(7):820-5. doi: 10.1111/j.1600-0501.2012.02463.x. Epub 2012 Mar 27.
PubMed 22458589Palmer W, Crawford-Sykes A, Rose RE. Donor site morbidity following iliac crest bone graft. West Indian Med J. 2008 Nov;57(5):490-2.
PubMed 19565981Al-Abedalla K, Torres J, Cortes AR, Wu X, Nader SA, Daniel N, Tamimi F. Bone Augmented With Allograft Onlays for Implant Placement Could Be Comparable With Native Bone. J Oral Maxillofac Surg. 2015 Nov;73(11):2108-22. doi: 10.1016/j.joms.2015.06.151. Epub 2015 Jun 20.
PubMed 26126920Schlee M, Dehner JF, Baukloh K, Happe A, Seitz O, Sader R. Esthetic outcome of implant-based reconstructions in augmented bone: comparison of autologous and allogeneic bone block grafting with the pink esthetic score (PES). Head Face Med. 2014 May 28;10:21. doi: 10.1186/1746-160X-10-21.
PubMed 24885136Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
PubMed 23247591Lorenz J, Schlee M, Al-Maawi S, Chia P, Sader RA, Ghanaati S. Variant Purification of an Allogeneic Bone Block. Acta Stomatol Croat. 2017 Jun;51(2):141-147. doi: 10.15644/asc51/2/7.
PubMed 28827851Trajkovski B, Jaunich M, Muller WD, Beuer F, Zafiropoulos GG, Houshmand A. Hydrophilicity, Viscoelastic, and Physicochemical Properties Variations in Dental Bone Grafting Substitutes. Materials (Basel). 2018 Jan 30;11(2):215. doi: 10.3390/ma11020215.
PubMed 29385747Corbella S, Alberti A, Calciolari E, Taschieri S, Francetti L. Enamel matrix derivative for the treatment of partially contained intrabony defects: 12-month results. Aust Dent J. 2019 Mar;64(1):27-34. doi: 10.1111/adj.12654. Epub 2018 Oct 15.
PubMed 30257036
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Allograft and Enamel Matrix Derivative and Allograft in Treatment of Intrabony Defects
- ClinicalTrials.gov ID
- NCT06041854
- Acronym / sponsor ID
- A02040122
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 18 Sep 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.
Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss.
All patients will receive full mouth scaling and root planing and be re-evaluated to assess patient cooperation and maintaining good oral hygiene. Subjects who showed persistent PPD ≥ 5 mm with radiographic evidence of periodontal intrabony defect presence will be included and will be randomly allocated to one of two treatment groups.One group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative. second group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft .Clinical periodontal parameters (PI, GBI, PPD, CAL) will be re-evaluated at 3, 6 and 9 months after surgery. CBCT will be taken after 9 months of surgery and the defect measurements will be recorded
Detailed description
primary goal of periodontal therapy is not arrest the tissue destruction caused periodontal disease only, but also to reconstruct the tissue lost caused by infectious process. Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss. Surgical intervention is considered the treatment of choice for deep intrabony defects, which have not resolved following completion of cause-related periodontal therapy.
In general, periodontal studies showed that healing of periodontal defect after conventional periodontal therapy by collagenous tissue with epithelial cell migration within the gingival connective tissue and along the root surface. Therefore, a various of methods and techniques used to prevent epithelial ingrowth to the defect site and permit only a selective periodontal cells proliferation in attempt to regenerate periodontal tissues. Regenerative procedures including the use of certain types of bone replacement materials, barrier membranes, enamel matrix derivative (EMD), or various combinations thereof have been shown to facilitate periodontal regeneration characterized histologically by formation of root cementum, periodontal ligament, and alveolar bone and result superior in clinical, and radiographical patient reported outcomes compared to access flap surgery alone.
Various bone graft and bone substitutes materials can be helpful in the tissue restoration. This bone graft include autogenous bone graft, allografts, xenografts, and alloplastic materials. Autologous bone is considered the gold standard because of its biological activity due to vital cells and growth factors. Yet, the autologous bone from intra-oral donor sites is of restricted quantities and availability, and the bone tissue obtained from the iliac crest is described to show faster resorption. Moreover, the harvesting of autologous bone often requires a second surgical site associated with an additional bone defect, potential donor site morbidity limiting their application.
In recent years, the use of allogeneic human bone has been favored worldwide, and several histological and morphological studies have demonstrated that, there is no difference in the final stage of incorporation and new bone formation between allografts and autografts. Thus, the application of processed allogenic bone tissue is a reliable and predictable alternative.
Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.
Maxgraft® is allograft bone substitute processed by the Cells+Tissuebank Austria with a special cleaning process (Allotec® process). The purification process keeps the structural features and the interconnected macroporosity of human bone. It preserve natural bone structure and collagen content, therefore it serves as a scaffold for natural bone regeneration and has the potential of complete remodeling into patients' own bone. It is available as purely cancellous as well as cortico-cancellous granules and blocks.
Recently, better outcomes have been reported with a combination of xenograft and enamel matrix derivative (EMD) as it combines the osteoconductive and space-making properties of bone grafts with the ability of bioactive materials to stimulate periodontal regeneration. The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex.
To the best of our knowledge, no previous studies have been performed for assessment of the efficacy of using emdogain with maxgraft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Test group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograft
| Arm | Type | Receives |
|---|---|---|
| freeze-dried bone allograft combined with enamel matrix derivative | Experimental | Procedure: Freeze-dried bone allograft combined with Enamel Matrix derivativeThe intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative. |
| freeze-dried bone allograft | Active comparator | Procedure: Freeze-dried bone allograftThe intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range between 30-50 years.
- Patients with stage III periodontitis, will be diagnosed on the basis of probing pocket depth and clinical attachment loss.
- Presence of at least one or more radiographically detectable intrabony defect with clinical periodontal pocket depth (PPD) ≥5 mm, clinical attachment loss ≥5 mm, and radiographic depth of the intrabony defect ≥3 mm.
- No periodontal therapy within the last 6 months
Key exclusion criteria (5 listed)
- Smoker and alcoholic patient.
- Patient with any signs, symptoms or history of systemic disease that might affect the periodontium and interfere with healing process.
- Pregnant patients.
- Patient who has traumatic occlusion.
- Uncooperative patient
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 |
|---|---|---|
| Freeze-dried bone allograft combined with Enamel Matrix derivativeThe intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft mixed with enamel matrix derivative. Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle.The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex. | Procedure or surgery | freeze-dried bone allograft combined with enamel matrix derivative |
| Freeze-dried bone allograftThe intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft . Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed. | Procedure or surgery | freeze-dried bone allograft |
Primary outcome
Radiographic bone defect fill
Time frame: at baseline and 9 months
Cone Beam Computed Tomography (CBCT) will be taken prior to periodontal surgery and after 9 months. The amount of reduction in the IBD measurements (defect resolution)
4 secondary outcomes
Clinical attachment level
Time frame: CAL will be measured at base line, 3, 6, 9 months postoperative
Probing pocket depth
Time frame: PD will be measured at base line, 3, 6, 9 months postoperative
Plaque Index
Time frame: PI will be measured at base line, 3, 6, 9 months postoperative
Gingival Bleeding Index
Time frame: GBI will be measured at base line, 3, 6, 9 months postoperative
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 May 2024.
- Background: PubMed 28805207Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.
- Background: PubMed 9118274Garrett S. Periodontal regeneration around natural teeth. Ann Periodontol. 1996 Nov;1(1):621-66. doi: 10.1902/annals.1996.1.1.621.
- Background: PubMed 2066446Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.
- Background: PubMed 25315019Reynolds MA, Kao RT, Camargo PM, Caton JG, Clem DS, Fiorellini JP, Geisinger ML, Mills MP, Nares S, Nevins ML. Periodontal regeneration - intrabony defects: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S105-7. doi: 10.1902/jop.2015.140378. Epub 2014 Oct 15.
- Background: PubMed 25867990Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.
- Background: PubMed 25867987Sculean A, Nikolidakis D, Nikou G, Ivanovic A, Chapple IL, Stavropoulos A. Biomaterials for promoting periodontal regeneration in human intrabony defects: a systematic review. Periodontol 2000. 2015 Jun;68(1):182-216. doi: 10.1111/prd.12086.
- Background: PubMed 31860134Nibali L, Koidou VP, Nieri M, Barbato L, Pagliaro U, Cairo F. Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:320-351. doi: 10.1111/jcpe.13237.
- Background: PubMed 22458589Mertens C, Decker C, Seeberger R, Hoffmann J, Sander A, Freier K. Early bone resorption after vertical bone augmentation--a comparison of calvarial and iliac grafts. Clin Oral Implants Res. 2013 Jul;24(7):820-5. doi: 10.1111/j.1600-0501.2012.02463.x. Epub 2012 Mar 27.
- Background: PubMed 19565981Palmer W, Crawford-Sykes A, Rose RE. Donor site morbidity following iliac crest bone graft. West Indian Med J. 2008 Nov;57(5):490-2.
- Background: PubMed 26126920Al-Abedalla K, Torres J, Cortes AR, Wu X, Nader SA, Daniel N, Tamimi F. Bone Augmented With Allograft Onlays for Implant Placement Could Be Comparable With Native Bone. J Oral Maxillofac Surg. 2015 Nov;73(11):2108-22. doi: 10.1016/j.joms.2015.06.151. Epub 2015 Jun 20.
- Background: PubMed 24885136Schlee M, Dehner JF, Baukloh K, Happe A, Seitz O, Sader R. Esthetic outcome of implant-based reconstructions in augmented bone: comparison of autologous and allogeneic bone block grafting with the pink esthetic score (PES). Head Face Med. 2014 May 28;10:21. doi: 10.1186/1746-160X-10-21.
- Background: PubMed 23247591Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
- Individual participant dataSharing planned: No
Related trials for Intrabony Periodontal Defect
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use
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.
Jilan Youssef, Professor study chair
Mansoura 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 Freeze-dried bone allograft combined with Enamel Matrix derivative and Freeze-dried bone allograft in people with Intrabony Periodontal Defect, run by Mansoura 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 May 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?
Radiographic bone defect fill (time frame: at baseline and 9 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 NCT06041854, which also lists 22 linked publications.
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 May 2024.