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Dental Implant PlacementCTG_implantNCT03728283

Implant Placement in Combination With Connective Tissue Grafting

A study testing implant placement in combination with connective tissue grafting and Implant placement in people with Dental Implant Placement, run by Aristotle University Of Thessaloniki.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Suitable subjects who were in need of implant placement were randomised between two groups; Group-A (NA=23) received crestal implant placement. In Group-B (NB=23) a CTG harvested from the palate was stabilised over the implant-neck. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Dental Implant Placement
What is being tested?
implant placement in combination with connective tissue grafting and Implant placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
10 Jan 2014to 30 Jul 2016
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • above 18 years of age
  • no active periodontal disease (Plaque Index ≤15%, Gingival Index ≤20%, <20% of sites equal to or deeper than 5mm).

Who cannot join

  • medical conditions that contraindicated surgical implant placement,
  • medication that interfered with bone metabolism,
  • pregnancy or lactation,
  • inadequate dimensions of the alveolar ridge or grafted bone at the surgical site,
  • tooth extraction 3 months prior to the study.

About this study

Official title: Tissue Changes Following Connective Tissue Grafting and Two-stage Implant Placement. A Randomised Clinical Trial

Suitable subjects who were in need of implant placement were randomised between two groups; Group-A (NA=23) received crestal implant placement. In Group-B (NB=23) a CTG harvested from the palate was stabilised over the implant-neck. At the time of implant placement (T0), Groups were categorized as having thin mucosa ≤2.5mm at the surgical site, or thick mucosa >2.5mm. Mucosa thickness, width of keratinised tissue (WKT), crestal bone levels and bone thickness were determined at T0 and at the two-stage surgery (T1).

Read the detailed description

Initially, 48 patients were recruited from new referrals to the Lab of Preventive Dentistry, Periodontology and Implant Biology, Aristotle University of Thessaloniki (AUTh) for surgical placement of at least one implant located in the upper/lower jaw in the anterior/posterior segment.

Study design An initial screening visit included full-mouth periodontal assessment, radiographic examination, fulfillment of inclusion/exclusion criteria and suitable patients (n=48) were randomised into either treatment Group; in the control Group (Group-A), a conventional surgical protocol was followed for implant placement, while in the test Group (Group-B) implants were placed in conjunction with an autologous CTG. Each Group was further categorized as having thin mucosa (≤2.5mm for Subgroups-AI/-BI) or thick mucosa (>2.5mm for Subgroups-AII/-BII) at the implantation site before implant placement (baseline=T0). Implants were exposed 3-4 months later (T1).

Surgical procedures A single implant system (Osseotite, Certain, parallel wall, Biomet 3i, Florida, USA; implants of 3.25/4.0 mm in diameter) was used in all cases. At T0, following local anaesthesia (lidocaine hydrochloride 2%, epinephrine 1:100000, Lignospan standard, Septodont, France), crestal incisions were performed and full-thickness flaps were raised for implant placement. Implants were placed at the level of the alveolar crest following the manufacturer's surgical guidelines and a two-stage protocol. Flaps were repositioned using absorbable sutures (polygalactic acid 5/0 sutures; PGA, medipac, Greece). In Group-B, a similar protocol was followed as in Group-A, with the exception that following implant placement a CTG was harvested from the palate, between the maxillary canine and the first molar (Liu \& Weisgold, 2002) and was stabilised onto the lingual flap using a horizontal mattress suture. Standardised dimensions of the CTG (11×6×1.5mm) were sought to cover the implant's shoulder and extend 3-5 mm on the buccal and the lingual aspect of the alveolar ridge (Fig. 1). Scoring of the periosteum for coronal advancement of the flaps was mainly performed in Group-B (16 of 23 cases).

Post-operative care Post-operative pain and oedema were controlled by Ibuprofen, 600 mg. All participants were prescribed antibiotics (Amoxicillin, 500 mg per 8 hours for 5 days) and were instructed to rinse twice daily with chlorhexidine digluconate (0.12%) and to abstain from oral hygiene in the test area for one week. Any post-operative adverse events (i.e. swelling, suppuration, flap dehiscence, persistent pain) were recorded upon suture removal ten days after surgery.

Clinical assessments

The following clinical assessments were performed at the implant site at T0 and were repeated at T1:

A periodontal probe (Hu-Friedy XP-23/QW) that had an endo-stop attached on it was used to determine the distances which were finally measured in millimetres by a digital calliper (Mitutoyo Europe GmbH) for precision.

Mucosa thickness (mm) was measured by bone sounding on the alveolar crest and at 2- and 4 mm apically, both on the buccal and the lingual aspects.

The WKT (mm) was measured on the mid-buccal aspect of the implant site. The Implant to Bone Crest (I-BC) distance (mm) was measured at four sites, mid-buccally, mid-lingually, mesially and distally and was determined as the distance of the osseous crest from the implant platform.

The Thickness of the buccal and lingual bone (mm) was measured at the level of the implant shoulder and at 3- and 6 mm apically, using a customised metallic calliper (Ustomed, Tuttlingen, Germany). The inner part of one jaw firmly touched the periphery of the screw hole within the implant fixture and the opposing jaw firmly touched the osseous surface of the alveolar ridge at the predetermined depth.

Radiographic assessment Intraoral digital radiography and the VixWin™ Platinum Gendex software (Hatfield, PA, USA) was utilised to linearly assess the I-BC distance on the mesial/distal aspect at T0 and T1. The long-cone paralleling technique was used at a distance of 10 cm between the x-ray head and the digital sensor which was attached to a custom-made silicone bite block for reproducible radiographs.

Being tested
implant placement in combination with connective tissue grafting, Implant placement
Keywords
connective tissue graft, implant surgery, two-stage implants, mucosa thickness, crestal bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implant placement in combination with connective tissue graftingProcedure or surgery

    A connective tissue graft of standardised dimensions was harvested from the palate under local anaesthesia and was stabilised over the implant's neck

  • Implant placementOther

    Implants were placed following teh manufacturer's instructions

Study groups in NCT03728283
Study groupRoleWhat they receive
Conventional Implant placementActive comparatorconventional implant placement following the manufacturer's instructions
Receives: Other: Implant placement
Implant and Connective tissue graftingExperimentalimplant placement in combination with connective tissue grafting
Receives: Procedure: implant placement in combination with connective tissue grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mucosa thickness

    measured by bone sounding on the alveolar crest and at 2- and 4 mm apically, both on the buccal and the lingual aspects

    Measured: implant placement to implant exposure

Secondary outcomes (4)
  1. Width of keratinised mucosa

    measured on the mid-buccal aspect of the implant site

    Measured: Implant placement to implant exposure

  2. Implant to Bone Crest (I-BC) distance

    measured at four sites, mid-buccally, mid-lingually, mesially and distally and was determined as the distance of the osseous crest from the implant platform.

    Measured: Implant placement to implant exposure

  3. Thickness of the buccal and lingual bone

    measured at the level of the implant shoulder and at 3- and 6 mm apically, using a customised metallic calliper (Ustomed, Tuttlingen, Germany). The inner part of one jaw firmly touched the periphery of the screw hole within the implant fixture and the opposing jaw firmly touched the osseous surface of the alveolar ridge at the predetermined depth.

    Measured: Implant placement to implant exposure

  4. radiographic Implant to Bone Crest (I-BC) distance

    Intraoral digital radiography and the VixWin™ Platinum Gendex software (Hatfield, PA, USA) was utilised to linearly assess the I-BC distance on the mesial/distal aspect at T0 and T1. The long-cone paralleling technique was used at a distance of 10 cm between the x-ray head and the digital sensor which was attached to a custom-made silicone bite block for reproducible radiographs.

    Measured: Implant placement to implant exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start10 Jan 2014
  3. Primary completion30 Apr 2016
  4. Study completion30 Jul 2016

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
Prospective, randomised, parallel-group, controlled clinical trial (Altman et al. 2001) with allocation ratio 1:1,
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728283
Sponsor's protocol ID
AUTh_5/30-09-2014
Acronym
CTG_implant
Status last verified
Nov 2018
First submitted
31 Oct 2018
Last updated
5 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu CL, Weisgold AS. Connective tissue graft: a classification for incision design from the palatal site and clinical case reports. Int J Periodontics Restorative Dent. 2002 Aug;22(4):373-9.

    PubMed 12212684
  • Papapetros D, Karagiannis V, Konstantinidis A, Apatzidou DA. Interim tissue changes following connective tissue grafting and two-stage implant placement. A randomized clinical trial. J Clin Periodontol. 2019 Sep;46(9):958-968. doi: 10.1111/jcpe.13159. Epub 2019 Jul 24.

    PubMed 31206749

Questions about this trial

What is this clinical trial studying?

A study testing implant placement in combination with connective tissue grafting and Implant placement in people with Dental Implant Placement, run by Aristotle University Of Thessaloniki.

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 2 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 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Mucosa thickness (time frame: implant placement to implant exposure). 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 NCT03728283, which also lists 2 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 5 Nov 2018.

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