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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
subepithelial connective tissue graft, Submerged Tenting Abutment and Sub-crestal Implant Placement
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

zainab.hafez@miuegypt.edu.eg

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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 groups in NCT07714265
Study groupRoleWhat they receive
Subepithelial Connective Tissue Graft (SCTG)ExperimentalParticipants 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 AbutmentExperimentalParticipants 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 PlacementExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted20 Jul 2026
  2. Study start17 Jul 2026 (estimated)
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

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)
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 37052357
  • Thoma 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 35904229
  • Thoma 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

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.

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