Peri-implant Soft Tissue DeficiencyNCT07714265
Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant Placement
A study testing subepithelial connective tissue graft, Submerged Tenting Abutment and Sub-crestal Implant Placement in people with Peri-implant Soft Tissue Deficiency and Partial Edentulism, run by Misr International University at 1 site in Egypt.
Trial summary
Peri-implant soft tissue thickness is an important determinant of the long-term stability and success of dental implants. Patients with a thin peri-implant soft tissue phenotype are at increased risk of soft tissue recession, marginal bone loss, and compromised esthetic and functional outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peri-implant Soft Tissue Deficiency, Partial Edentulism, Tooth Loss
- What is being tested?
- subepithelial connective tissue graft, Submerged Tenting Abutment and Sub-crestal Implant Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jul 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older.
- Partially edentulous patients requiring a single dental implant in the posterior mandible.
- Thin peri-implant soft tissue phenotype (<2 mm).
- Horizontal alveolar ridge width of at least 6 mm.
- Vertical bone height of at least 10-12 mm, confirmed radiographically.
- Adequate interarch restorative space for implant-supported restoration.
Show all 9Show fewer
- Medically healthy (American Society of Anesthesiologists [ASA] Physical Status I or II).
- Good oral hygiene.
- Able and willing to provide written informed consent.
Who cannot join
- Local pathological lesions affecting the surgical site.
- Smoking.
- Pregnancy or breastfeeding.
- Alcohol abuse or parafunctional habits that may compromise implant survival or wound healing.
- Medical or local conditions that could interfere with osseointegration, soft tissue healing, or study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zeinab H Abd El Rahman, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Misr International University Dental Clinic Complex
Cairo
Baraa M Nagy, BDS, +201063278917, baraa2480582@miuegypt.edu.eg
Zeinab H Abd El Rahman, PhD, zainab.hafez@miuegypt.edu.eg
About this study
Official title: Evaluation of Peri-implant Soft Tissue Thickness Following Augmentation Using Subepithelial Connective Tissue Graft Versus Submerged Tenting Abutment Versus Sub-crestal Implant Placement: A Randomized Controlled Clinical Trial
Peri-implant soft tissue thickness is an important determinant of the long-term stability and success of dental implants. Patients with a thin peri-implant soft tissue phenotype are at increased risk of soft tissue recession, marginal bone loss, and compromised esthetic and functional outcomes. Subepithelial connective tissue graft (SCTG) is considered the gold standard for soft tissue augmentation; however, it requires harvesting tissue from the palate, increasing surgical complexity, operative time, and postoperative morbidity. Less invasive approaches, including submerged tenting abutments and subcrestal implant placement, have been proposed as alternatives to improve peri-implant soft tissue dimensions while reducing patient morbidity, but direct comparative clinical evidence remains limited.
This investigator-initiated, single-center, randomized, parallel-group clinical trial will compare three approaches for peri-implant soft tissue augmentation in patients with a thin peri-implant soft tissue phenotype requiring a single dental implant in the posterior mandible. Eligible implant sites will be randomly assigned in a 1:1:1 allocation ratio to receive either subepithelial connective tissue grafting, submerged tenting abutment placement, or subcrestal implant placement during implant surgery.
The primary objective is to compare changes in peri-implant soft tissue thickness using three-dimensional digital intraoral scanning over a 12-month follow-up period. Secondary objectives include evaluation of keratinized tissue width, clinical soft tissue thickness, histological characteristics of peri-implant soft tissue, peri-implant crestal bone level changes, postoperative pain, operative time, patient-reported satisfaction, and postoperative complications. The results of this study are expected to provide evidence regarding whether minimally invasive treatment approaches can achieve clinical outcomes comparable to connective tissue grafting while reducing surgical morbidity and improving patient-centered outcomes.
Read the detailed description
Peri-implant soft tissue thickness is a critical factor influencing the biological stability, function, and long-term success of dental implant therapy. A thin peri-implant soft tissue phenotype has been associated with increased marginal bone remodeling, soft tissue recession, and compromised peri-implant tissue stability. Consequently, augmentation of peri-implant soft tissues has become an important component of implant treatment planning, particularly in patients with thin soft tissue phenotypes.
Subepithelial connective tissue grafting (SCTG) is widely regarded as the reference standard for peri-implant soft tissue augmentation because of its predictable ability to increase tissue volume and improve peri-implant tissue stability. Nevertheless, harvesting autogenous connective tissue from the palate increases operative time, donor-site morbidity, postoperative discomfort, and surgical complexity. These limitations have encouraged the development of less invasive techniques capable of enhancing peri-implant soft tissue dimensions while minimizing patient morbidity.
Submerged tenting abutments have recently been introduced as a minimally invasive method for maintaining soft tissue space during submerged healing following implant placement. By supporting the overlying soft tissues throughout the healing phase, these abutments may promote increased soft tissue thickness without the need for connective tissue harvesting. Although preliminary clinical reports have shown encouraging outcomes, direct comparisons with connective tissue grafting remain limited.
Subcrestal implant placement has also been proposed as an alternative method for improving peri-implant soft tissue dimensions. Positioning the implant platform approximately 2 mm below the alveolar crest may increase the vertical dimension of peri-implant soft tissues without requiring grafting procedures or additional prosthetic components. While this technique has demonstrated favorable biological behavior in previous studies, evidence directly comparing it with connective tissue grafting and submerged tenting abutments remains scarce.
Advances in digital intraoral scanning have enabled accurate, reproducible, and non-invasive three-dimensional assessment of peri-implant soft tissue changes over time. Digital volumetric analysis provides objective measurements while reducing operator-dependent variability associated with conventional clinical measurements. Combining digital assessment with clinical, radiographic, histological, and patient-reported outcomes provides a comprehensive evaluation of treatment effectiveness.
This investigator-initiated, single-center, randomized, parallel-group interventional clinical trial will enroll 33 implant sites in medically healthy adults requiring single implant placement in the posterior mandible and presenting with a thin peri-implant soft tissue phenotype (<2 mm). Implant sites will be randomly allocated in a 1:1:1 ratio to one of three intervention groups: (1) equicrestal implant placement with subepithelial connective tissue grafting, (2) equicrestal implant placement with a submerged tenting abutment, or (3) subcrestal implant placement without grafting or tenting abutment. Randomization will be performed using a computer-generated sequence with allocation concealment through opaque sealed envelopes. Outcome assessors and the biostatistician will remain blinded throughout data collection and analysis, whereas blinding of participants and the operating surgeon is not feasible because of the nature of the surgical interventions.
The primary outcome will be the change in peri-implant soft tissue thickness measured by standardized three-dimensional intraoral scanning and digital volumetric analysis. Secondary outcomes include histological characteristics of peri-implant soft tissues, clinical soft tissue thickness, width of keratinized mucosa, peri-implant crestal bone level changes assessed using standardized radiographs, postoperative pain measured using a visual analog scale (VAS), operative time, patient satisfaction measured using the Oral Health Impact Profile-14 (OHIP-14), and postoperative complications. Participants will be followed according to the predefined study schedule for 12 months after implant placement using standardized clinical, digital, radiographic, and patient-reported assessments.
The results of this study will provide high-quality comparative evidence regarding three contemporary approaches for peri-implant soft tissue augmentation. By evaluating volumetric, clinical, histological, radiographic, and patient-centered outcomes within the same randomized clinical trial, the study aims to identify treatment strategies that maximize peri-implant soft tissue stability while minimizing surgical morbidity. The findings may contribute to evidence-based decision-making for clinicians managing patients with thin peri-implant soft tissue phenotypes and support the development of less invasive treatment protocols for implant therapy.
- Being tested
- subepithelial connective tissue graft, Submerged Tenting Abutment, Sub-crestal Implant Placement
- Keywords
- Dental Implant, Peri-implant Soft Tissue, Soft Tissue Augmentation, Tenting Healing Abutment, Subepithelial Connective Tissue Graft, Digital Volumetric Analysis, Randomized Controlled Trial, Posterior Mandible, Submerged Tenting Abutment, Thin Peri-implant Phenotype, Subcrestal Implant Placement, SCTG, Digital Intraoral Scanner
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subepithelial connective tissue graftProcedure or surgery
Also called SCTG
Harvesting of an autogenous connective tissue graft from the palate and placement over an equicrestally positioned dental implant to augment peri-implant soft tissue thickness.
Submerged Tenting AbutmentDevice
Placement of a submerged low-profile tenting healing abutment over an equicrestally positioned dental implant to support peri-implant soft tissue during healing.
Sub-crestal Implant PlacementProcedure or surgery
Also called Subcrestal Implant Placement
Placement of a dental implant approximately 2 mm apical to the alveolar crest without soft tissue grafting or tenting abutment placement.
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial Connective Tissue Graft (SCTG) | Experimental | Participants assigned to this arm will receive equi-crestal dental implant placement followed by augmentation of the peri-implant soft tissue using an autogenous subepithelial connective tissue graft harvested from the palate. The graft will be positioned over the implant site to increase peri-implant soft tissue thickness before primary flap closure. Receives: Procedure: subepithelial connective tissue graft |
| Submerged Tenting Abutment | Experimental | Participants assigned to this arm will receive equicrestal dental implant placement followed by placement of a submerged low-profile tenting healing abutment beneath the flap to support peri-implant soft tissue contour during healing without connective tissue grafting. Receives: Device: Submerged Tenting Abutment |
| Subcrestal Implant Placement | Experimental | Participants assigned to this arm will receive dental implant placement approximately 2 mm below the alveolar crest without connective tissue grafting or placement of a submerged tenting abutment. Receives: Procedure: Sub-crestal Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peri-implant Soft Tissue Thickness
Change in peri-implant soft tissue thickness from baseline measured using three-dimensional digital intraoral scanning (Medit Intraoral Scanner) and digital volumetric analysis (Medit Design software). Measurements will be performed by blinded outcome assessors and expressed in millimeters (mm).
Measured: Baseline, 3 months, 6 months, and 12 months after implant placement.
Secondary outcomes (5)
Histological Characteristics of Peri-implant Soft Tissue
Histological evaluation of peri-implant soft tissue biopsy specimens obtained during second-stage implant surgery. Tissue sections will be stained with hematoxylin and eosin and Masson's trichrome to assess epithelial thickness and collagen density.
Measured: 3 months
Clinical Peri-implant Soft Tissue Thickness
Clinical measurement of peri-implant soft tissue thickness using standardized transgingival probing.
Measured: Baseline, 3 months, 6 months, and 12 months
Postoperative Pain
Participant-reported postoperative pain measured using a 10-point Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = worst pain imaginable (very severe pain). Higher scores indicate greater postoperative pain.
Measured: Daily during the first 10 postoperative days
Peri-implant Crestal Bone Level Changes
Changes in peri-implant crestal bone level assessed using standardized periapical radiographs analyzed with ImageJ software.
Measured: Baseline, 3 months, 6 months, and 12 months
Width of Keratinized Tissue
Clinical measurement of peri-implant keratinized tissue width using a standardized periodontal probe.
Measured: Baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start17 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peri-implant Soft Tissue DeficiencyStudies 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
- Parallel groups
- Model description
- This is a single-center, randomized, three-arm, parallel-group clinical trial. Eligible participants requiring a single implant in the posterior mandible and presenting with a thin peri-implant soft tissue phenotype will be randomly assigned in a 1:1:1 allocation ratio to receive one of three interventions: subepithelial connective tissue graft (SCTG), submerged tenting abutment, or sub-crestal implant placement. Participants will remain in their assigned intervention group throughout the study, with follow-up assessments performed over 12 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hani E elnahass, Phd, Study chair, Professor, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo UniversityZeinab E Abd El Rahman, Phd, Study director, Lecturer, Department of Oral Medicine, Faculty of Oral and Dental Medicine, Misr International University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714265
- Sponsor's protocol ID
- PER3253019
- Other IDs
- PER3253019, MIU-IRB-2526-025
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the time of registration, a decision regarding sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be considered in accordance with institutional policies, participant informed consent, applicable regulations, and journal requirements.
Publications
Lee CT, Tran D, Tsukiboshi Y, Min S, Kim SK, Ayilavarapu S, Weltman R. Clinical efficacy of soft-tissue augmentation on tissue preservation at immediate implant sites: A randomized controlled trial. J Clin Periodontol. 2023 Jul;50(7):1010-1020. doi: 10.1111/jcpe.13816. Epub 2023 Apr 13.
PubMed 37052357Thoma DS, Gasser TJW, Hammerle CHF, Strauss FJ, Jung RE. Soft tissue augmentation with a volume-stable collagen matrix or an autogenous connective tissue graft at implant sites: Five-year results of a randomized controlled trial post implant loading. J Periodontol. 2023 Feb;94(2):230-243. doi: 10.1002/JPER.22-0226. Epub 2022 Oct 28.
PubMed 35904229Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
PubMed 27310522
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-implant Soft Tissue Thickness Following Augmentation Using Subepithelial Connective Tissue Graft Versus Submerged Tenting Abutment Versus Sub-crestal Implant Placement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07714265
- Acronym / sponsor ID
- PER3253019
- Keywords
- Dental Implant, Peri-implant Soft Tissue, Soft Tissue Augmentation, Tenting Healing Abutment, Subepithelial Connective Tissue Graft, Digital Volumetric Analysis, Randomized Controlled Trial, Posterior Mandible
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 17 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 20 Jul 2026 (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.
Peri-implant soft tissue thickness is an important determinant of the long-term stability and success of dental implants. Patients with a thin peri-implant soft tissue phenotype are at increased risk of soft tissue recession, marginal bone loss, and compromised esthetic and functional outcomes. Subepithelial connective tissue graft (SCTG) is considered the gold standard for soft tissue augmentation; however, it requires harvesting tissue from the palate, increasing surgical complexity, operative time, and postoperative morbidity. Less invasive approaches, including submerged tenting abutments and subcrestal implant placement, have been proposed as alternatives to improve peri-implant soft tissue dimensions while reducing patient morbidity, but direct comparative clinical evidence remains limited.
This investigator-initiated, single-center, randomized, parallel-group clinical trial will compare three approaches for peri-implant soft tissue augmentation in patients with a thin peri-implant soft tissue phenotype requiring a single dental implant in the posterior mandible. Eligible implant sites will be randomly assigned in a 1:1:1 allocation ratio to receive either subepithelial connective tissue grafting, submerged tenting abutment placement, or subcrestal implant placement during implant surgery.
The primary objective is to compare changes in peri-implant soft tissue thickness using three-dimensional digital intraoral scanning over a 12-month follow-up period. Secondary objectives include evaluation of keratinized tissue width, clinical soft tissue thickness, histological characteristics of peri-implant soft tissue, peri-implant crestal bone level changes, postoperative pain, operative time, patient-reported satisfaction, and postoperative complications. The results of this study are expected to provide evidence regarding whether minimally invasive treatment approaches can achieve clinical outcomes comparable to connective tissue grafting while reducing surgical morbidity and improving patient-centered outcomes.
Detailed description
Peri-implant soft tissue thickness is a critical factor influencing the biological stability, function, and long-term success of dental implant therapy. A thin peri-implant soft tissue phenotype has been associated with increased marginal bone remodeling, soft tissue recession, and compromised peri-implant tissue stability. Consequently, augmentation of peri-implant soft tissues has become an important component of implant treatment planning, particularly in patients with thin soft tissue phenotypes.
Subepithelial connective tissue grafting (SCTG) is widely regarded as the reference standard for peri-implant soft tissue augmentation because of its predictable ability to increase tissue volume and improve peri-implant tissue stability. Nevertheless, harvesting autogenous connective tissue from the palate increases operative time, donor-site morbidity, postoperative discomfort, and surgical complexity. These limitations have encouraged the development of less invasive techniques capable of enhancing peri-implant soft tissue dimensions while minimizing patient morbidity.
Submerged tenting abutments have recently been introduced as a minimally invasive method for maintaining soft tissue space during submerged healing following implant placement. By supporting the overlying soft tissues throughout the healing phase, these abutments may promote increased soft tissue thickness without the need for connective tissue harvesting. Although preliminary clinical reports have shown encouraging outcomes, direct comparisons with connective tissue grafting remain limited.
Subcrestal implant placement has also been proposed as an alternative method for improving peri-implant soft tissue dimensions. Positioning the implant platform approximately 2 mm below the alveolar crest may increase the vertical dimension of peri-implant soft tissues without requiring grafting procedures or additional prosthetic components. While this technique has demonstrated favorable biological behavior in previous studies, evidence directly comparing it with connective tissue grafting and submerged tenting abutments remains scarce.
Advances in digital intraoral scanning have enabled accurate, reproducible, and non-invasive three-dimensional assessment of peri-implant soft tissue changes over time. Digital volumetric analysis provides objective measurements while reducing operator-dependent variability associated with conventional clinical measurements. Combining digital assessment with clinical, radiographic, histological, and patient-reported outcomes provides a comprehensive evaluation of treatment effectiveness.
This investigator-initiated, single-center, randomized, parallel-group interventional clinical trial will enroll 33 implant sites in medically healthy adults requiring single implant placement in the posterior mandible and presenting with a thin peri-implant soft tissue phenotype (<2 mm). Implant sites will be randomly allocated in a 1:1:1 ratio to one of three intervention groups: (1) equicrestal implant placement with subepithelial connective tissue grafting, (2) equicrestal implant placement with a submerged tenting abutment, or (3) subcrestal implant placement without grafting or tenting abutment. Randomization will be performed using a computer-generated sequence with allocation concealment through opaque sealed envelopes. Outcome assessors and the biostatistician will remain blinded throughout data collection and analysis, whereas blinding of participants and the operating surgeon is not feasible because of the nature of the surgical interventions.
The primary outcome will be the change in peri-implant soft tissue thickness measured by standardized three-dimensional intraoral scanning and digital volumetric analysis. Secondary outcomes include histological characteristics of peri-implant soft tissues, clinical soft tissue thickness, width of keratinized mucosa, peri-implant crestal bone level changes assessed using standardized radiographs, postoperative pain measured using a visual analog scale (VAS), operative time, patient satisfaction measured using the Oral Health Impact Profile-14 (OHIP-14), and postoperative complications. Participants will be followed according to the predefined study schedule for 12 months after implant placement using standardized clinical, digital, radiographic, and patient-reported assessments.
The results of this study will provide high-quality comparative evidence regarding three contemporary approaches for peri-implant soft tissue augmentation. By evaluating volumetric, clinical, histological, radiographic, and patient-centered outcomes within the same randomized clinical trial, the study aims to identify treatment strategies that maximize peri-implant soft tissue stability while minimizing surgical morbidity. The findings may contribute to evidence-based decision-making for clinicians managing patients with thin peri-implant soft tissue phenotypes and support the development of less invasive treatment protocols for implant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a single-center, randomized, three-arm, parallel-group clinical trial. Eligible participants requiring a single implant in the posterior mandible and presenting with a thin peri-implant soft tissue phenotype will be randomly assigned in a 1:1:1 allocation ratio to receive one of three interventions: subepithelial connective tissue graft (SCTG), submerged tenting abutment, or sub-crestal implant placement. Participants will remain in their assigned intervention group throughout the study, with follow-up assessments performed over 12 months.
| Arm | Type | Receives |
|---|---|---|
| Subepithelial Connective Tissue Graft (SCTG) | Experimental | Procedure: subepithelial connective tissue graftParticipants assigned to this arm will receive equi-crestal dental implant placement followed by augmentation of the peri-implant soft tissue using an autogenous subepithelial connective tissue graft harvested from the palate. The graft will be positioned over the implant site to increase peri-implant soft tissue thickness before primary flap closure. |
| Submerged Tenting Abutment | Experimental | Device: Submerged Tenting AbutmentParticipants assigned to this arm will receive equicrestal dental implant placement followed by placement of a submerged low-profile tenting healing abutment beneath the flap to support peri-implant soft tissue contour during healing without connective tissue grafting. |
| Subcrestal Implant Placement | Experimental | Procedure: Sub-crestal Implant PlacementParticipants assigned to this arm will receive dental implant placement approximately 2 mm below the alveolar crest without connective tissue grafting or placement of a submerged tenting abutment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 20 years or older.
- Partially edentulous patients requiring a single dental implant in the posterior mandible.
- Thin peri-implant soft tissue phenotype (<2 mm).
- Horizontal alveolar ridge width of at least 6 mm.
- Vertical bone height of at least 10-12 mm, confirmed radiographically.
Key exclusion criteria (5 listed)
- Local pathological lesions affecting the surgical site.
- Smoking.
- Pregnancy or breastfeeding.
- Alcohol abuse or parafunctional habits that may compromise implant survival or wound healing.
- Medical or local conditions that could interfere with osseointegration, soft tissue healing, or study participation
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 |
|---|---|---|
| subepithelial connective tissue graftAlso: SCTGHarvesting of an autogenous connective tissue graft from the palate and placement over an equicrestally positioned dental implant to augment peri-implant soft tissue thickness. | Procedure or surgery | Subepithelial Connective Tissue Graft (SCTG) |
| Submerged Tenting AbutmentPlacement of a submerged low-profile tenting healing abutment over an equicrestally positioned dental implant to support peri-implant soft tissue during healing. | Device | Submerged Tenting Abutment |
| Sub-crestal Implant PlacementAlso: Subcrestal Implant PlacementPlacement of a dental implant approximately 2 mm apical to the alveolar crest without soft tissue grafting or tenting abutment placement. | Procedure or surgery | Subcrestal Implant Placement |
Primary outcome
Change in Peri-implant Soft Tissue Thickness
Time frame: Baseline, 3 months, 6 months, and 12 months after implant placement.
Change in peri-implant soft tissue thickness from baseline measured using three-dimensional digital intraoral scanning (Medit Intraoral Scanner) and digital volumetric analysis (Medit Design software). Measurements will be performed by blinded outcome assessors and expressed in millimeters (mm).
5 secondary outcomes
Histological Characteristics of Peri-implant Soft Tissue
Time frame: 3 months
Clinical Peri-implant Soft Tissue Thickness
Time frame: Baseline, 3 months, 6 months, and 12 months
Postoperative Pain
Time frame: Daily during the first 10 postoperative days
Peri-implant Crestal Bone Level Changes
Time frame: Baseline, 3 months, 6 months, and 12 months
Width of Keratinized Tissue
Time frame: Baseline, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 37052357Lee CT, Tran D, Tsukiboshi Y, Min S, Kim SK, Ayilavarapu S, Weltman R. Clinical efficacy of soft-tissue augmentation on tissue preservation at immediate implant sites: A randomized controlled trial. J Clin Periodontol. 2023 Jul;50(7):1010-1020. doi: 10.1111/jcpe.13816. Epub 2023 Apr 13.
- Results publication: PubMed 35904229Thoma DS, Gasser TJW, Hammerle CHF, Strauss FJ, Jung RE. Soft tissue augmentation with a volume-stable collagen matrix or an autogenous connective tissue graft at implant sites: Five-year results of a randomized controlled trial post implant loading. J Periodontol. 2023 Feb;94(2):230-243. doi: 10.1002/JPER.22-0226. Epub 2022 Oct 28.
- Results publication: PubMed 27310522Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
- Individual participant dataSharing planned: Undecided. At the time of registration, a decision regarding sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be considered in accordance with institutional policies, participant informed consent, applicable regulations, and journal requirements.
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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.
Zeinab H Abd El Rahman, PhD contact
Hani E elnahass, Phd study chair
Professor, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Zeinab E Abd El Rahman, Phd study director
Lecturer, Department of Oral Medicine, Faculty of Oral and Dental Medicine, Misr International 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 subepithelial connective tissue graft, Submerged Tenting Abutment and Sub-crestal Implant Placement in people with Peri-implant Soft Tissue Deficiency and Partial Edentulism, run by Misr International 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 9 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baraa M Nagy, BDS (+201063278917, baraa2480582@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peri-implant Soft Tissue Thickness (time frame: Baseline, 3 months, 6 months, and 12 months after implant placement.). 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 NCT07714265, which also lists 3 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 Jul 2026.