PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load
Phase: NA
Conditions: Dental Implants
Sponsor: Ain Shams University

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Document date: 21\12\2022 
 
“PEEK versus Titanium Customized Healing Abutments: 
Evaluation of Peri-implant Soft Tissues and Sulcus Fluid 
Bacterial Load” 
(A randomized Controlled clinical study) 
Thesis Protocol 
Submitted to the Department of Oral Medicine, Periodontology and Oral Diagnosis,  
Faculty of Dentistry, Ain Shams University 
In partial fulfillment of the requirements of the master’s degree in Periodontology 
 
 
 
By 
Samar Fawki Fakhr El Din El Desouki 
Master’s degree student in the Department of Oral Medicine, Periodontology & 
Oral Diagnosis, Faculty of Dentistry, Ain Shams University. 
BDS 2017  
(Faculty of Dentistry, MSA University) 
SamarFakhrEldin@dent.asu.edu.eg 
 
 
 
 
 
 
 
 

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Under the Supervision of: 
Associate Prof. Dr. Ahmed El Sayed Hamed Amr 
Associate Professor of Oral Medicine, Periodontology and Oral 
diagnosis Faculty of Dentistry, Ain-Shams University 
 
 
Dr. Hadeel Gamal Salem Al Malahy 
Lecturer of Oral Medicine, Periodontology and Oral Diagnosis 
Faculty of Dentistry, Ain Shams University Faculty of Dentistry 
 
 
Associate Prof. Dr.Nashwa El-Khazragy 
Assistant professor of clinical pathology/Hematology 
Faculty of Medicine, Ain Shams University  
 
 
 
Ain Shams University 
Faculty of Dentistry 
2022 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
Topic 
Page 
I. Abstract 
4 
II. Background 
5 
III. Research Question 
7 
V. Aims (Objectives) 
8 
V. Hypothesis 
9 
VI. Ethical Considerations 
10 
VII. Study design 
10 
VIII. Materials and Methods 
• Study setting  
• Sample Size 
• Study Procedures 
11-14 
IX. Statistical Analysis 
16 
X. Funding of the Study 
16 
XI. References 
17 
 
 
 
 
 
 
 
 
 
 
 
 

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I-Abstract 
Statement of problem: Polyetheretherketone (PEEK) is a polymer that has many 
potential uses in dentistry because of esthetic and biologic reasons for maintaining the 
health of peri-implant soft tissues during healing. Polyetheretherketone (PEEK) healing 
abutments have superior properties such as biocompatibility, inert chemical properties, 
white color, and decreased liability for biofilm accumulation. 
 
Aim of the study: This study will be carried out to compare two different 
materials, Polyetheretherketone (PEEK) vs Titanium (Ti) used to fabricate 
customized healing abutments placed simultaneously with a guided delayed 
dental implant. 
 
Materials and Methods: This will involve a clinical assessment of peri-
implant soft tissue changes. Moreover, peri-implant sulcus fluid (PISF) will 
be measured for total bacterial load. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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II. Background 
Successful aesthetic implant therapy has several sequential goals, such as 
prosthetically driven 3D implant placement. Implant placement must be done in 
the ideal position to support the restoration and the surrounding soft and hard 
tissues. The placement of a definitive restoration should also be in harmony 
with the adjacent natural teeth and surrounding soft tissue.(Funato et al., 2007). 
Guided implant surgery can provide precise, predictable, and safe implant 
placement. Computer-generated surgical guides vary in design according to the 
dental condition (edentulous or partially edentulous), type of support (tooth, 
mucosa, or bone), and degree of limitation (non-limiting, partially limiting, or 
completely limiting) (Vercruyssen et al., 2014; Pyo et al., 2019). 
The use of healing abutments has the function of enabling adequate healing of 
peri-implant soft tissue and promoting a good profile of peri-implant mucosa 
that allows an adequate emergence profile of the prostheses supported by the 
implant. They are available in different lengths and project through the soft 
tissue into the oral cavity. Janakievski stated that prefabricated healing 
abutments are unable to support the supracrestal soft tissues because of their 
circular profile. Therefore, a custom healing abutment is preferred because it 
provides a replica of the definitive restoration to the patient’s gingival 
architecture. (Molina et al., 2017; Susin et al., 2019). 
An evaluation of the use of customized healing abutments has been performed, 
aiming to assess the possible advantages associated with this treatment 
modality. This procedure allows for the peri implant tissue and improve 
aesthetics until crown delivery. CAD/CAM allows the fabrication of high-
quality implant abutments from solid blocks of different materials. (Joda et al., 
2016; Finelle et al., 2017; Ruales-Carrera et al., 2019). 
The contours of the healing abutment are based on the contours of a 
provisionally designed definitive prosthesis. The healing abutment promotes 
tissue healing and obtains contours that are well matched with the contours of 
the definitive prosthesis. (Berberi et al., 2014; Mehra et al., 2016; Yunus et al., 
2016). 
  

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Currently, healing abutments made of polymers such as polyetheretherketone 
(PEEK), which have been used in orthopedic surgery, are used in dentistry, 
because of esthetic and biologic reasons for maintaining the health of peri-
implant soft tissues during healing. (Volpe et al., 2008). 
Polyetheretherketone (PEEK) healing abutments can be chosen instead of 
titanium healing abutments because of their superior properties, such as 
biocompatibility, inert chemical properties, white color, and decreased liability 
for biofilm accumulation. (Rea et al., 2017). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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II-Research Question 
 
“Do PEEK healing abutment may have a favorable effect on peri implant soft 
tissue that may be related to the superior biological properties of PEEK 
regarding both decreased biofilm accumulation and healing stimulation?” 
 
                                   PICOTS Elements: 
Patient/Problem 
Patients that are eligible for implant 
placement within inclusion criteria. 
Intervention 
PEEK customized healing abutment. 
Comparator  
Titanium customized healing abutment. 
Outcome  
Clinical evaluation of peri-implant soft 
tissue changes. 
Time  
1 month after implantation. 
4 months after implantation (just before 
prosthetic procedures) 
Setting 
Faculty 
of 
Dentistry, 
Ain 
Shams 
University. 
 
 
 
 
 
 
 
 
 
 
 
 

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IV.Aim of the study 
This study will be carried out to compare two different materials 
Polyetheretherketone (PEEK) vs Titanium (Ti) used to fabricate customized 
healing abutments placed simultaneously with guided delayed dental implant. 
 
Primary outcome: 
Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD), 
Plaque Index (PI) score and Width of keratinized tissue (WKT). 
 
Secondary outcome: 
Biochemical evaluation of peri‑implant sulcus fluid (PISF) total bacterial load. 
 
Clinical Relevance: 
The result will affect the gold standard in choosing the healing abutment for 
implant patients, regarding which one offers less biofilm accumulation& healing 
stimulation. 
 
 
 
 
 
 
 
 
 

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• Hypothesis: 
Our study suggests that if we used customized healing abutment 
synthesized from PEEK, this may have a favorable effect on peri 
implant soft tissues regarding decreased plaque accumulation and 
healing stimulation in compared to the customized conventional 
titanium healing abutments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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VI.Ethical consideration 
•Risk and discomfort of patients: This research will be conducted with 
consideration of patient safety and with attempts to reduce any discomfort to 
patient, risks include postoperative pain, edema that can be controlled with 
medication. 
•Minimization of the risk: Patient baseline vitals will be taken before any 
medical procedure to ensure patients safety. Moreover, all medical operation 
will be conduct under standardized infection control procedure. 
•Criteria for Discontinuation of Study/patient: patient will be allowed to 
leave study if developed any complications either related to the study 
intervention or related to the general condition of the patient. The patient will 
have the right to withdraw from the study at any time.  
•Benefits to the Patients and to the Community: patients will receive an 
aesthetically and functionally implant with no cost. The community will benefit 
from this study by having a wider range of healing abutments to choose from. 
•Privacy: All patients identification including patient data and pictures will be 
locked and not shared.  
•Confidentiality: patient’s data will be treated with utmost confidentiality. In 
which no personal other than the researchers will be able to view the patient’s 
data. 
•Data Management: All patient’s data will be saved on researcher’s personal 
laptop that are not connected to any intranet connections and no copies will be 
made in any kind of database. 
•Consent Procedures if Applicable: any medical procedures and photographs 
will have a printed written consent form. 
 
•Patient Informed Consent Form: a proper consent form will be formulated 
&signed by the patient before starting any procedure. 

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VII. Study Design: 
Randomized, controlled, parallel design, two arms clinical trial. 
 
VII. Materials and Methods: 
 
• Study Setting: Faculty of Dentistry, Ain Shams University. 
 
 
• Sample Size Calculation: A power analysis was designed to have 
adequate power to apply a two-sided statistical test of the null hypothesis 
that there is no difference would be found between different groups. By 
adopting an alpha level of (0.05), a beta of (0.2) (i.e., power=80%) and an 
effect size (d) of (1.32) calculated based on the results of a previous study, 
the predicted sample size (n) was a total of (22) cases (i.e., 11 cases per 
group). Two patients will be added to each group to compensate for any 
loss. Sample size calculation was performed using G*Power version 
3.1.9.7   
 
• Eligibility criteria: 
 
Inclusion Criteria: 
1.Patients should be systematically free from any disease as according to Cornell 
Medical Index-Health Questionnaire (Pendleton et al., 2004). 
2.Both genders. 
3.Age from 20-50 years. 
4.Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard 
implant, with no need for additional bone and soft tissue augmentation procedures. 
(Beretta et al., 2019) 
5.Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 
2016). 
6.BuccoLingual bone width ≥ 6 mm. 
7. Mesio distal space ≥ 7 mm (Jensen, 1989) 
8.Sound Mesial and distal neighboring teeth. 
9.At least 6 natural teeth remaining in the same arch . 

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10.Mouth opening   ≥ 30mm. 
11.Enough keratinized mucosa. 
12.Thick phenotype. 
 
 
Exclusion Criteria: 
1) Poor oral hygiene condition. 
2)Pregnant and lactating females. 
3)Smokers.  
 
Justification for Exclusions: 
To reduce any confounding factors and bias that may affect the results of this study. 
 
 
Study procedures: 
1- Randomization and allocation concealment technique: Patients will be 
randomly allocated according to predetermined computer-generated 
randomization using www.Randomizer.org  
 
 
2- Details of the interventions, testing and follow up: 
• Group I (Customized PEEK Healing Abutment):  
13 patients will receive guided delayed implant and a customized 
PEEK healing abutment placed simultaneously with implant 
surgery. 
• Group II (Customized Titanium Healing Abutment):  
13 patients will receive guided delayed implant and a customized 
titanium healing abutment placed simultaneously with implant 
surgery. 
 
 
 
 

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Study protocol and surgical steps 
   A) Presurgical procedures: 
1)Detailed clinical examination, full history, and radiographic 
examination (CBCT) will be performed initially to aid in patients’ 
selection. 
2)After enrollment, all participants will sign the informed consent.  
3)All participants will be subjected to periodontal phase I treatment 
including periodontal supra- and sub-gingival debridement and oral 
hygiene instructions. 
4)Preliminary impression for upper arch and cast fabrication will be 
made. 
5)Pre-operative virtual planning for implant placement in ideal 3D 
position by appropriate software and preparation of digital surgical guide. 
6)According to virtual implant future position healing abutment will be 
fabricated by milling machine. 
 
B) Surgical procedures: 
1)After local anesthesia administration, flapless fully guided osteotomy 
site preparation and implant will be place through the guide (Fully 
digital) 
2)Check the ISQ to exceed or equal 70 unit. 
3)A customized PEEK or Titanium healing abutment will be placed. 
 
       Assessment: 
• 
Clinical assessment. 
• 
Biochemical assessment. 
 
 The following clinical parameters will be recorded for the individuals on 
the following 1,4 months post implantation (Rüdin et al., 1970) 
 

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Clinical Parameters Included: 
 
Probing Depth (PD): (Caton, 1980) 
Will be measured from the gingival margin to the depth of the pocket at 
four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the 
nearest millimeter using UNC periodontal probe The average of the three 
facial points will be recorded as the facial probing depth (FPD), while the 
mid-lingual point will be recorded as the lingual probing depth. 
 
Plaque Index (PI) score: (Mombelli et al., 1987) 
0 = No detection of plaque  
1= Plaque only recognized by running a probe across the smooth 
marginal surface of the implant. 
2 =Plaque can be seen by the naked accumulation eye greater than 25% 
3 Abundance of soft matter 
 
Gingival Index (GI)score: (Lobene et al.,1986) 
0= Normal. 
1=Mild inflammation, slight change in color, little change in texture of 
any portion of gingival unit. 
2=Mild inflammation for entire gingival unit. 
3= Moderate inflammation of gingival unit. 
4= Sever inflammation of gingival unit. 
  
Gingival Bleeding Time Index (GBTI): (Muhlemann &Son, 1971) 
Locate areas of gingival sulcus bleeding upon gentle probing and 
recognize 
presence of early gingival inflammation 
1 = healthy looking papillary and marginal gingiva, bleeding on probing 
2 = bleeding on probing and color change in gingiva 

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3 = bleeding on probing, color change, slight edema 
4 = bleeding on probing, color change, obvious edema 
5 = spontaneous bleeding, color change, marked edema or ulceration. 
 
 
 
Width of keratinized tissue (WKT): (Newman et al., 2012) 
The distance between the gingival margin and mucogingival junction at 
the mid-buccal area, which was measured by a UNC periodontal probe 
with 1 mm accuracy. 
 
PISF samples: 
PISF sampling will be performed at the dental implant sites. Using 
standardized paper strips Periopaper. Paper strips will be placed at the 
entrance of the peri‐implant sulcus and will be inserted to a standardized 
depth of 1 mm at each site regardless of the PD. In order not to affect the 
actual fluid volume, sampling time will also standardize as 30 s. Samples 
with evidence of gingival bleeding were not included. The PISF samples 
will then be placed in sterile, wrapped Eppendorf tubes and stored until the 
day of laboratory analysis (Tözüm et al., 2007). 
 
3- Blinding techniques: single blinding 
IX. Statistical Analysis 
The obtained results will be collected, tabulated, and subjected to appropriate 
statistical analysis. 
X. Funding of the Study 
This study will be personally funded by the researcher. 
 
 
 
 
 
 

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