Dental Implant PlacementNCT04309006
Buccal Soft Tissue Contour Changes After Immediate Implant Placement with or Without Connective Tissue Graft
A study testing CTG and customized healing abutment and CTG and conventional healing abutment in people with Dental Implant Placement, run by Misr International University at 2 sites in Egypt.
Trial summary
Statement of the problem: Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintain the soft tissue contour. Using connective tissue grafts enhances and maintains soft tissue stability. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Placement
- What is being tested?
- CTG and customized healing abutment and CTG and conventional healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2020to 1 Aug 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults at or above the age of 18.
- Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
- Sagittal root position type 1 as described by Kan et al(24).
- Good oral hygiene
- Patient accepts to provide an informed consent
Who cannot join
- Smokers
- Pregnant and lactating females.
- Medically compromised patients, as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (25)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
International Dental Contining Education Centre (IDCE)
Cairo
Misr International University
Cairo
About this study
Official title: Volumetric Evaluation of Buccal Soft Tissue Contour Using Customized Healing Abutment During Immediate Implant Placement with Connective Tissue Grafting. a Randomized Controlled Clinical Trial
Statement of the problem: Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintain the soft tissue contour. Using connective tissue grafts enhances and maintains soft tissue stability. However, the effect of the combined procedures for maintenance of the soft tissue morphology remains unclear. Purpose : The aim of the study is to evaluate the volumetric difference of buccal soft tissue contour around immediate implants placed with and without connective tissue grafts and customized healing abutments. Materials and Methods: Fifty-two patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 13 patients will randomly be assigned in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with connective tissue graft (CTG) and customized healing abutment, Group 2 (test group) IIP with CTG and healing abutment same diameter of the implant, Group 3 (test group) IIP and customized healing abutment, while the 4th group (control) IIP with healing abutment same diameter of the implant. Extra-oral scanning of the buccal contour will be carried out presurgical and at 3, 6, 9 and 12 months after surgery. Difference in contour gained will be compared to the original contour and between groups. Radiographic evaluation will be done using CBCT at 12 months to measure the bone width. In addition, soft tissue thickness, mid facial recession, gingival biotype, interdental papilla height, soft tissue peri- implant parameters and any surgical or prosthetic complications will be assessed.
Read the detailed description
After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. Using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (31). After implant placement, the allocation will be revealed to the practitioner for the type of the healing abutment to be used and whether connective tissue graft will be used or not.
Thirteen implants (intervention 1) will receive screw- retained customized healing abutment, and thirteen other implants in the 2nd intervention group will receive the conventional healing abutment of same diameter of the implant. In both groups connective tissue graft will be used. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place.
The fabrication of the customized healing abutment is as follows; the temporary cylindrical abutment will be screwed to the implant then flowable composite will be injected at the gingival margin level to adapt to the screw-retained temporary cylindrical abutments that will be sand-blasted for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque. Patients will be recalled for regular follow ups. Other thirteen implants (intervention 3) will receive screw- retained customized healing abutment, and for the control (the 4th group) group thirteen implants will receive the conventional healing abutment of same diameter of the implant. No connective tissue grafts are to be used in these two groups.
- Conditions
- Dental Implant Placement
- Being tested
- CTG and customized healing abutment, CTG and conventional healing abutment
- Keywords
- Immediate implant placement, Connective tissue graft, buccal soft tissue contour, customized healing abutment, volumetric analysis, cone beam computerized tomography (CBCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTG and customized healing abutmentProcedure or surgery
Also called zimmer biomed dental implants and connective tissue grafts and customized healing abutments
screw- retained customized healing abutment
CTG and conventional healing abutmentProcedure or surgery
Also called Zimmer biomed dental implants and connective tissue graft
conventional healing abutment
| Study group | Role | What they receive |
|---|---|---|
| CTG and customized healing abutment | Experimental | Customized healing abutment used with connective tissue graft Receives: Procedure: CTG and customized healing abutment |
| CTG and conventional healing abutment | Experimental | Conventional healing abutment (same diameter of the implant) used with connective tissue graft Receives: Procedure: CTG and conventional healing abutment |
| customized healing abutment | Active comparator | Customized healing abutment used without connective tissue graft Receives: Procedure: CTG and customized healing abutment |
| conventional healing abutment | Active comparator | Conventional healing abutment (same diameter of the implant) without connective tissue graft Receives: Procedure: CTG and conventional healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric analysis of buccal contour
Measuring changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin. This will be done using Extra oral scanning and 3D viewer software
Measured: Before surgery - 3 months - 6 months - 9 months - 12 months
Secondary outcomes (7)
Bucco-palatal width
Measured using Cone Beam CT
Measured: Before surgery - 12 months
Gingival thickness
Measured using Periodontal Probe
Measured: Before surgery - 6 months - 12 months
Mid facial recession
Measured with 3D viewer software
Measured: Before surgery - 3 months - 6 months - 9 months - 12 months
Interdental papillae height
Measured with 3D viewer software
Measured: Before surgery - 3 months - 6 months - 9 months - 12 months
Modified Plaque Index
Measured with periodontal probe
Measured: 3 months - 6 months - 9 months - 12 months
Modified Bleeding Index
Measured with periodontal probe
Measured: 3 months - 6 months - 9 months - 12 months
Patient satisfaction
Measured with Visual Analogue Scale (VAS) The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jul 2020
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Dental Implant PlacementStudies 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
- Factorial
- Model description
- The first factor is the use of connective tissue graft which includes two levels and the second factor is the use of healing abutment which includes two levels.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, Misr International University
- Investigators
- Ahmed I Abo El Futtouh, Master, Principal investigator, Clinical Director of Implant Program - Misr International UniversityKhaled Abdel-Ghaffar, Doctor, Study director, Minister of Higher Education and Scientific ResearchInas M El-Zayat, Doctor, Study director, Assoc.Prof - Operative department, Faculty of DentistryMariam S Hanna, Bsc, Study director, Dentist/Researcher - IDCENael A Mina, Bsc, Study chair, Misr International UniversityAbdel Rahman A Abdel Rahman, Master, Study chair, International Dental Contiuing EducationAhmed F Mostafa, Bsc, Study chair, International Dental Contiuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309006
- Sponsor's protocol ID
- PER8273003
- Status last verified
- Oct 2024
- First submitted
- 9 Mar 2020
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared
Publications
Buser D, Halbritter S, Hart C, Bornstein MM, Grutter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. doi: 10.1902/jop.2009.080360.
PubMed 19228101Kan JY, Rungcharassaeng K. Site development for anterior single implant esthetics: the dentulous site. Compend Contin Educ Dent. 2001 Mar;22(3):221-6, 228, 230-1; quiz 232.
PubMed 11913259Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26.
PubMed 25434568Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical complications of osseointegrated implants. J Prosthet Dent. 1999 May;81(5):537-52. doi: 10.1016/s0022-3913(99)70208-8.
PubMed 10220658Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87.
PubMed 21365054Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and recommended clinical procedures regarding surgical techniques. Int J Oral Maxillofac Implants. 2009;24 Suppl:272-8. No abstract available.
PubMed 19885450De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
PubMed 26373422Hammerle CH, Chen ST, Wilson TG Jr. Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets. Int J Oral Maxillofac Implants. 2004;19 Suppl:26-8. No abstract available.
PubMed 15635943Levine RA, Ganeles J, Kan J, Fava PL. 10 Keys for Successful Esthetic-Zone Single Implants: Importance of Biotype Conversion for Lasting Success. Compend Contin Educ Dent. 2018 Sep;39(8):522-529; quiz 530.
PubMed 30188147Lee CT, Tao CY, Stoupel J. The Effect of Subepithelial Connective Tissue Graft Placement on Esthetic Outcomes After Immediate Implant Placement: Systematic Review. J Periodontol. 2016 Feb;87(2):156-67. doi: 10.1902/jop.2015.150383. Epub 2015 Oct 15.
PubMed 26469808Kolerman R, Nissan J, Mijiritsky E, Hamoudi N, Mangano C, Tal H. Esthetic assessment of immediately restored implants combined with GBR and free connective tissue graft. Clin Oral Implants Res. 2016 Nov;27(11):1414-1422. doi: 10.1111/clr.12755. Epub 2016 Jan 7.
PubMed 26743894Cosyn J, Eghbali A, Hermans A, Vervaeke S, De Bruyn H, Cleymaet R. A 5-year prospective study on single immediate implants in the aesthetic zone. J Clin Periodontol. 2016 Aug;43(8):702-9. doi: 10.1111/jcpe.12571. Epub 2016 Jun 13.
PubMed 27120578Touati B, Guez G, Saadoun A. Aesthetic soft tissue integration and optimized emergence profile: provisionalization and customized impression coping. Pract Periodontics Aesthet Dent. 1999 Apr;11(3):305-14; quiz 316.
PubMed 10379291Saito H, Chu SJ, Reynolds MA, Tarnow DP. Provisional Restorations Used in Immediate Implant Placement Provide a Platform to Promote Peri-implant Soft Tissue Healing: A Pilot Study. Int J Periodontics Restorative Dent. 2016 Jan-Feb;36(1):47-52. doi: 10.11607/prd.1945.
PubMed 26697547del Castillo RA. Immediate provisionalization of a single-tooth implant with a temporary cylinder in one surgical appointment. Pract Proced Aesthet Dent. 2006 Jun;18(5):suppl 3-5. No abstract available.
PubMed 16903535
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Evaluation of Buccal Soft Tissue Contour Using Customized Healing Abutment During Immediate Implant Placement with Connective Tissue Grafting. a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04309006
- Acronym / sponsor ID
- PER8273003
- Conditions
- Dental Implant Placement
- Keywords
- Immediate implant placement, Connective tissue graft, buccal soft tissue contour, customized healing abutment, volumetric analysis, cone beam computerized tomography (CBCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 16 Mar 2020 (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.
Statement of the problem: Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintain the soft tissue contour. Using connective tissue grafts enhances and maintains soft tissue stability. However, the effect of the combined procedures for maintenance of the soft tissue morphology remains unclear. Purpose : The aim of the study is to evaluate the volumetric difference of buccal soft tissue contour around immediate implants placed with and without connective tissue grafts and customized healing abutments. Materials and Methods: Fifty-two patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 13 patients will randomly be assigned in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with connective tissue graft (CTG) and customized healing abutment, Group 2 (test group) IIP with CTG and healing abutment same diameter of the implant, Group 3 (test group) IIP and customized healing abutment, while the 4th group (control) IIP with healing abutment same diameter of the implant. Extra-oral scanning of the buccal contour will be carried out presurgical and at 3, 6, 9 and 12 months after surgery. Difference in contour gained will be compared to the original contour and between groups. Radiographic evaluation will be done using CBCT at 12 months to measure the bone width. In addition, soft tissue thickness, mid facial recession, gingival biotype, interdental papilla height, soft tissue peri- implant parameters and any surgical or prosthetic complications will be assessed.
Detailed description
After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. Using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (31). After implant placement, the allocation will be revealed to the practitioner for the type of the healing abutment to be used and whether connective tissue graft will be used or not.
Thirteen implants (intervention 1) will receive screw- retained customized healing abutment, and thirteen other implants in the 2nd intervention group will receive the conventional healing abutment of same diameter of the implant. In both groups connective tissue graft will be used. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place.
The fabrication of the customized healing abutment is as follows; the temporary cylindrical abutment will be screwed to the implant then flowable composite will be injected at the gingival margin level to adapt to the screw-retained temporary cylindrical abutments that will be sand-blasted for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque. Patients will be recalled for regular follow ups. Other thirteen implants (intervention 3) will receive screw- retained customized healing abutment, and for the control (the 4th group) group thirteen implants will receive the conventional healing abutment of same diameter of the implant. No connective tissue grafts are to be used in these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The first factor is the use of connective tissue graft which includes two levels and the second factor is the use of healing abutment which includes two levels.
| Arm | Type | Receives |
|---|---|---|
| CTG and customized healing abutment | Experimental | Procedure: CTG and customized healing abutmentCustomized healing abutment used with connective tissue graft |
| CTG and conventional healing abutment | Experimental | Procedure: CTG and conventional healing abutmentConventional healing abutment (same diameter of the implant) used with connective tissue graft |
| customized healing abutment | Active comparator | Procedure: CTG and customized healing abutmentCustomized healing abutment used without connective tissue graft |
| conventional healing abutment | Active comparator | Procedure: CTG and conventional healing abutmentConventional healing abutment (same diameter of the implant) without connective tissue graft |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults at or above the age of 18.
- Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
- Sagittal root position type 1 as described by Kan et al(24).
Key exclusion criteria (6 listed)
- Smokers
- Pregnant and lactating females.
- Medically compromised patients, as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (25)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
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 |
|---|---|---|
| CTG and customized healing abutmentAlso: zimmer biomed dental implants and connective tissue grafts and customized healing abutmentsscrew- retained customized healing abutment | Procedure or surgery | CTG and customized healing abutment, customized healing abutment |
| CTG and conventional healing abutmentAlso: Zimmer biomed dental implants and connective tissue graftconventional healing abutment | Procedure or surgery | CTG and conventional healing abutment, conventional healing abutment |
Primary outcome
Volumetric analysis of buccal contour
Time frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Measuring changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin. This will be done using Extra oral scanning and 3D viewer software
7 secondary outcomes
Bucco-palatal width
Time frame: Before surgery - 12 months
Gingival thickness
Time frame: Before surgery - 6 months - 12 months
Mid facial recession
Time frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Interdental papillae height
Time frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Modified Plaque Index
Time frame: 3 months - 6 months - 9 months - 12 months
Modified Bleeding Index
Time frame: 3 months - 6 months - 9 months - 12 months
Patient satisfaction
Time frame: 12 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 17 Oct 2024.
- Background: PubMed 19228101Buser D, Halbritter S, Hart C, Bornstein MM, Grutter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. doi: 10.1902/jop.2009.080360.
- Background: PubMed 11913259Kan JY, Rungcharassaeng K. Site development for anterior single implant esthetics: the dentulous site. Compend Contin Educ Dent. 2001 Mar;22(3):221-6, 228, 230-1; quiz 232.
- Background: PubMed 25434568Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26.
- Background: PubMed 10220658Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical complications of osseointegrated implants. J Prosthet Dent. 1999 May;81(5):537-52. doi: 10.1016/s0022-3913(99)70208-8.
- Background: PubMed 21365054Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87.
- Background: PubMed 19885450Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and recommended clinical procedures regarding surgical techniques. Int J Oral Maxillofac Implants. 2009;24 Suppl:272-8. No abstract available.
- Background: PubMed 26373422De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
- Background: PubMed 15635943Hammerle CH, Chen ST, Wilson TG Jr. Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets. Int J Oral Maxillofac Implants. 2004;19 Suppl:26-8. No abstract available.
- Background: PubMed 30188147Levine RA, Ganeles J, Kan J, Fava PL. 10 Keys for Successful Esthetic-Zone Single Implants: Importance of Biotype Conversion for Lasting Success. Compend Contin Educ Dent. 2018 Sep;39(8):522-529; quiz 530.
- Background: PubMed 26469808Lee CT, Tao CY, Stoupel J. The Effect of Subepithelial Connective Tissue Graft Placement on Esthetic Outcomes After Immediate Implant Placement: Systematic Review. J Periodontol. 2016 Feb;87(2):156-67. doi: 10.1902/jop.2015.150383. Epub 2015 Oct 15.
- Background: PubMed 26743894Kolerman R, Nissan J, Mijiritsky E, Hamoudi N, Mangano C, Tal H. Esthetic assessment of immediately restored implants combined with GBR and free connective tissue graft. Clin Oral Implants Res. 2016 Nov;27(11):1414-1422. doi: 10.1111/clr.12755. Epub 2016 Jan 7.
- Background: PubMed 27120578Cosyn J, Eghbali A, Hermans A, Vervaeke S, De Bruyn H, Cleymaet R. A 5-year prospective study on single immediate implants in the aesthetic zone. J Clin Periodontol. 2016 Aug;43(8):702-9. doi: 10.1111/jcpe.12571. Epub 2016 Jun 13.
- Individual participant dataSharing planned: Yes. All data can be shared
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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.
Ahmed I Abo El Futtouh, Master principal investigator
Clinical Director of Implant Program - Misr International University
Khaled Abdel-Ghaffar, Doctor study director
Minister of Higher Education and Scientific Research
Inas M El-Zayat, Doctor study director
Assoc.Prof - Operative department, Faculty of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTG and customized healing abutment and CTG and conventional healing abutment in people with Dental Implant Placement, run by Misr International University at 2 sites 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 7 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Volumetric analysis of buccal contour (time frame: Before surgery - 3 months - 6 months - 9 months - 12 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 NCT04309006, which also lists 39 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 17 Oct 2024.